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MERS 데이터셋

MERS 연구 데이터셋

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2023-11-07 2023-11-07 무기한 비네아
데이터 제공포맷 데이터 제공방식 데이터 파일용량 데이터 상품구분
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[상품설명] 중동호흡기증후군(Middle East Respiratory Syndrome, MERS)은 2012년 사우디 아라비아에서 보고되었다. 주로 요르단, 아랍에메리트, 카타르 등 중동 지역을 중심으로 확산되어 메르스코로나바이러스(MERS-CoV)로 명명되었는데, 원인 병원체는 베타코로나바이러스(Betacoronaviruses)이고 낙타 또는 박쥐 등의 동물을 매개로 전파되는 것으로 추정되었다. 개와 고양이 등의 반려동물은 수용체가 사람과 달라 전이되지 않는 것으로 알려졌다. MERS는 WHO 기준 치사율은 35.9%이며, 증세가 해소되면 더 이상 바이러스가 배양되지 않는 것으로 밝혀진 SARS와 달리 증세가 해소된 후에도 24시간 격리가 요구되는데, 처음 약 5.5일 간의 잠복 기간에는 증상이 없다가 급성호흡기증후군으로 이어지는 심각한 폐렴에 이를 수도 있고, 신부전증, 심막염 등의 증상이 보고되기도 하였다. 국내에서는 SARS와 마찬가지로 즉시 신고해야 하는 제1급 법정감염병 중 하나로 지정되었다. (참조: https://npt.kdca.go.kr/npt/biz/npp/portal/nppLwcrIcdMain.do, 질병관리청 감염병포털 감염병누리집) 본 데이터 셋은 MERS 관련 의학논문의 서지정보와 키워드 데이터셋을 구축하여 연구 및 분석에 활용할 수 있는 제작된 데이터셋이다. [데이터 출처] Pubmed, Pubmed Central 및 기타 사이트에 게시된 의학 논문 [데이터 가공방식] 의학 논문 및 보고서의 메타데이터, 추출 키워드 데이터셋 분석 [데이터 범위] 2006년~2023년에 발행된 PLoS ONE, International Journal of Environmental Research, Frontiers in Public Health, Scientific Reports, Frontiers in Immunology 등 1,000여 종 영문 의학 저널의 논문 39,000건"

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21691 114788 MERS protective Action protective title 202353 https://doi.org/10.1016/S1470-2045(20)30223-0 Lack of protective gear disrupts oncology care Roxanne Nelson 202005 pubmed None https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7146734/ 684 1470-2045 The Lancet. Oncology London : Lancet Pub. Group
152245 114788 MERS Cause Term cause title 58329 https://doi.org/10.34172/jrhs.2020.13 Neglected Major Causes of Death Much Deadlier Than COVID-19 Jalal Poorolajal 202005 Editorial PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7585746/ 3332 Journal of Research in Health Sciences
361396 114788 MERS Colombia Region Colombia title 콜롬비아 203115 https://doi.org/10.1016/S0140-6736(21)01239-3 More social discontent than pandemic-related risk perception in Colombia Alvaro J Idrovo 202107 pubmed None https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8233035/ 38 0140-6736 Lancet (London, England) London : Elsevier.
568611 114788 MERS health Term health title 건강 38244 https://doi.org/10.2471/BLT.20.010320 Public health round-up 202003 News PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7047037/ 524 0042-9686 Bulletin of the World Health Organization Geneva : World Health Organization,.
726399 114788 MERS COVID-19 Disease COVID-19 title 코로나-19 203441 https://doi.org/10.1016/S0140-6736(22)01067-4 Memorialising COVID-19 Danielle Ofri 202206 pubmed None https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/9212448/ 38 0140-6736 Lancet (London, England) London : Elsevier.
745305 114788 MERS personal Term personal author 63722 https://doi.org/10.1177/0003065120981733 The Magical and the My-Person in Psychoanalysis During the Covid Pandemic Paola M. Contreras 202101 A Covid Panel PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7809333/ 3522 Journal of the American Psychoanalytic Association
3751 114788 MERS reported Action reported abstract 26009 https://doi.org/10.1001/jama.2021.18178 Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial Writing Committee for the REMAP-CAP Investigators|||Lise J Estcourt|||Alexis F Turgeon|||Zoe K McQuilten|||Bryan J McVerry|||Farah Al-Beidh|||Djillali Annane|||Yaseen M Arabi|||Donald M Arnold|||Abigail Beane|||Philippe B?gin|||Wilma van Bentum-Puijk|||Lindsay R Berry|||Zahra Bhimani|||Janet E Birchall|||Marc J M Bonten|||Charlotte A Bradbury|||Frank M Brunkhorst|||Meredith Buxton|||Jeannie L Callum|||Micha?l Chass?|||Allen C Cheng|||Matthew E Cove|||James Daly|||Lennie Derde|||Michelle A Detry|||Menno De Jong|||Amy Evans|||Dean A Fergusson|||Matthew Fish|||Mark Fitzgerald|||Claire Foley|||Herman Goossens|||Anthony C Gordon|||Iain B Gosbell|||Cameron Green|||Rashan Haniffa|||Heli Harvala|||Alisa M Higgins|||Thomas E Hills|||Veronica C Hoad|||Christopher Horvat|||David T Huang|||Cara L Hudson|||Nao Ichihara|||Emma Laing|||Abigail A Lamikanra|||Fran?ois Lamontagne|||Patrick R Lawler|||Kelsey Linstrum|||Edward Litton|||Elizabeth Lorenzi|||Sheila MacLennan|||John Marshall|||Daniel F McAuley|||John F McDyer|||Anna McGlothlin|||Shay McGuinness|||Gail Miflin|||Stephanie Montgomery|||Paul R Mouncey|||Srinivas Murthy|||Alistair Nichol|||Rachael Parke|||Jane C Parker|||Nicole Priddee|||Damian F J Purcell|||Luis F Reyes|||Peter Richardson|||Nancy Robitaille|||Kathryn M Rowan|||Jennifer Rynne|||Hiroki Saito|||Marlene Santos|||Christina T Saunders|||Ary Serpa Neto|||Christopher W Seymour|||Jon A Silversides|||Alan A Tinmouth|||Darrell J Triulzi|||Anne M Turner|||Frank van de Veerdonk|||Timothy S Walsh|||Erica M Wood|||Scott Berry|||Roger J Lewis|||David K Menon|||Colin McArthur|||Ryan Zarychanski|||Derek C Angus|||Steve A Webb|||David J Roberts|||Manu Shankar-Hari 202111 Trial PMC {{{ Abstract }}} !!{{ Importance: }} The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. !!{{ Objective: }} To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. !!{{ Design, setting, and participants: }} The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. !!{{ Interventions: }} The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). !!{{ Main outcomes and measures: }} The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. !!{{ Results: }} Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. !!{{ Conclusions and relevance: }} Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. !!{{ Trial registration: }} ClinicalTrials.gov Identifier: NCT02735707 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8491132/ 1093 0098-7484 JAMA Chicago : American Medical Association
21722 114788 MERS implication Term implication title 202876 https://doi.org/10.1182/blood.2020009966 Vaccinations in CLL: implications for COVID-19 Mazyar Shadman|||Chaitra Ujjani 202101 Comment pubmed None https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7820880/ 1048 0006-4971 Blood [New York] : Elsevier.
1159 114788 MERS performed Action performed abstract 7662 https://doi.org/10.1099/jmm.0.001346 Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Teagan F. Paton|||Ian Marr|||Zoe O’Keefe|||Timothy J. J. Inglis 202104 Other Type PMC Introduction The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial. Gap Statement In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic. Methodology We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems). Results The 95 and 99% limits of detection were 1.01 copies μl ?1 (5.05 copies per reaction) and 2.80 copies μl ?1 (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and ?2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48?100%], specificity 100% [95% CI 96.52?100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment. Conclusion Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8289214/ 161 0022-2615 Journal of Medical Microbiology London : Microbiology Society.
1165 114788 MERS purification Action purification abstract 정제 7662 https://doi.org/10.1099/jmm.0.001346 Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Teagan F. Paton|||Ian Marr|||Zoe O’Keefe|||Timothy J. J. Inglis 202104 Other Type PMC Introduction The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial. Gap Statement In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic. Methodology We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems). Results The 95 and 99% limits of detection were 1.01 copies μl ?1 (5.05 copies per reaction) and 2.80 copies μl ?1 (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and ?2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48?100%], specificity 100% [95% CI 96.52?100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment. Conclusion Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8289214/ 161 0022-2615 Journal of Medical Microbiology London : Microbiology Society.
1167 114788 MERS reagent Term reagent abstract 7662 https://doi.org/10.1099/jmm.0.001346 Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Teagan F. Paton|||Ian Marr|||Zoe O’Keefe|||Timothy J. J. Inglis 202104 Other Type PMC Introduction The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial. Gap Statement In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic. Methodology We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems). Results The 95 and 99% limits of detection were 1.01 copies μl ?1 (5.05 copies per reaction) and 2.80 copies μl ?1 (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and ?2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48?100%], specificity 100% [95% CI 96.52?100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment. Conclusion Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8289214/ 161 0022-2615 Journal of Medical Microbiology London : Microbiology Society.
1171 114788 MERS RNA extraction Term RNA extraction abstract RNA 추출 7662 https://doi.org/10.1099/jmm.0.001346 Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Teagan F. Paton|||Ian Marr|||Zoe O’Keefe|||Timothy J. J. Inglis 202104 Other Type PMC Introduction The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial. Gap Statement In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic. Methodology We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems). Results The 95 and 99% limits of detection were 1.01 copies μl ?1 (5.05 copies per reaction) and 2.80 copies μl ?1 (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and ?2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48?100%], specificity 100% [95% CI 96.52?100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment. Conclusion Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8289214/ 161 0022-2615 Journal of Medical Microbiology London : Microbiology Society.
1177 114788 MERS SARS-CoV-2 RT-PCR Term SARS-CoV-2 RT-PCR abstract 7662 https://doi.org/10.1099/jmm.0.001346 Development, deployment and in-field demonstration of mobile coronavirus SARS-CoV-2 Nucleic acid amplification test Teagan F. Paton|||Ian Marr|||Zoe O’Keefe|||Timothy J. J. Inglis 202104 Other Type PMC Introduction The evolving SARS-CoV-2 coronavirus pandemic presents a series of challenges to clinical diagnostic services. Many proprietary PCR platforms deployed outside centralised laboratories have limited capacity to upscale when public health demands increase. We set out to develop and validate an open-platform mobile laboratory for remote area COVID-19 diagnosis, with a subsequent field trial. Gap Statement In regional Western Australia, molecular diagnostic support is limited to near point-of-care devices. We therefore aimed to demonstrate open-platform capability in a rapidly deployable format within the context of the COVID-19 pandemic. Methodology We compared, selected and validated components of a SARS-CoV-2 RT-PCR assay in order to establish a portable molecular diagnostics laboratory. The optimal combination of PCR assay equipment, reagents and consumables required for operation to national standards in regional laboratories was identified. This comprised RNA extraction and purification (QuickGene-480, Kurabo, Japan), a duplex RT-PCR assay (Logix Smart COVID-19, Co-Diagnostics, USA), a Myra liquid handling robot (Biomolecular Systems, Australia) and a magnetic induction thermal cycler (MIC, Biomolecular Systems). Results The 95 and 99% limits of detection were 1.01 copies μl ?1 (5.05 copies per reaction) and 2.80 copies μl ?1 (14.00 copies per reaction) respectively. The Co-Diagnostics assay amplified both SARS-CoV-1 and ?2 RNA but showed no other cross reactivity. Qualitative results aligned with the reference laboratory SARS-CoV-2 assay (sensitivity 100% [95 % CI 96.48?100%], specificity 100% [95% CI 96.52?100%]). In field trials, the laboratory was operational within an hour of arrival on-site, can process up to 36 samples simultaneously, produces results in two and a half hours from specimen reception, and performed well during six consecutive runs during a 1 week deployment. Conclusion Our mobile laboratory enables an adaptive response to increased test demand, and unlike many proprietary point-of-care PCR systems, rapid substitution with an alternative assay if gene targets change or reagent supply chains fail. We envisage operation of this RT-PCR assay as a standby capability to meet varying regional test demands under public health emergency operations guidance. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8289214/ 161 0022-2615 Journal of Medical Microbiology London : Microbiology Society.
3753 114788 MERS secondary outcomes Term secondary outcomes abstract 26009 https://doi.org/10.1001/jama.2021.18178 Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial Writing Committee for the REMAP-CAP Investigators|||Lise J Estcourt|||Alexis F Turgeon|||Zoe K McQuilten|||Bryan J McVerry|||Farah Al-Beidh|||Djillali Annane|||Yaseen M Arabi|||Donald M Arnold|||Abigail Beane|||Philippe B?gin|||Wilma van Bentum-Puijk|||Lindsay R Berry|||Zahra Bhimani|||Janet E Birchall|||Marc J M Bonten|||Charlotte A Bradbury|||Frank M Brunkhorst|||Meredith Buxton|||Jeannie L Callum|||Micha?l Chass?|||Allen C Cheng|||Matthew E Cove|||James Daly|||Lennie Derde|||Michelle A Detry|||Menno De Jong|||Amy Evans|||Dean A Fergusson|||Matthew Fish|||Mark Fitzgerald|||Claire Foley|||Herman Goossens|||Anthony C Gordon|||Iain B Gosbell|||Cameron Green|||Rashan Haniffa|||Heli Harvala|||Alisa M Higgins|||Thomas E Hills|||Veronica C Hoad|||Christopher Horvat|||David T Huang|||Cara L Hudson|||Nao Ichihara|||Emma Laing|||Abigail A Lamikanra|||Fran?ois Lamontagne|||Patrick R Lawler|||Kelsey Linstrum|||Edward Litton|||Elizabeth Lorenzi|||Sheila MacLennan|||John Marshall|||Daniel F McAuley|||John F McDyer|||Anna McGlothlin|||Shay McGuinness|||Gail Miflin|||Stephanie Montgomery|||Paul R Mouncey|||Srinivas Murthy|||Alistair Nichol|||Rachael Parke|||Jane C Parker|||Nicole Priddee|||Damian F J Purcell|||Luis F Reyes|||Peter Richardson|||Nancy Robitaille|||Kathryn M Rowan|||Jennifer Rynne|||Hiroki Saito|||Marlene Santos|||Christina T Saunders|||Ary Serpa Neto|||Christopher W Seymour|||Jon A Silversides|||Alan A Tinmouth|||Darrell J Triulzi|||Anne M Turner|||Frank van de Veerdonk|||Timothy S Walsh|||Erica M Wood|||Scott Berry|||Roger J Lewis|||David K Menon|||Colin McArthur|||Ryan Zarychanski|||Derek C Angus|||Steve A Webb|||David J Roberts|||Manu Shankar-Hari 202111 Trial PMC {{{ Abstract }}} !!{{ Importance: }} The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. !!{{ Objective: }} To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. !!{{ Design, setting, and participants: }} The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. !!{{ Interventions: }} The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). !!{{ Main outcomes and measures: }} The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. !!{{ Results: }} Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. !!{{ Conclusions and relevance: }} Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. !!{{ Trial registration: }} ClinicalTrials.gov Identifier: NCT02735707 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8491132/ 1093 0098-7484 JAMA Chicago : American Medical Association
4502 114788 MERS Result Term result abstract 결과 41782 https://doi.org/10.1186/s12889-021-11168-y Incidence of PTSD and generalized anxiety symptoms during the first wave of COVID-19 outbreak: an exploratory study of a large sample of the Italian population Eleonora Brivio|||Serena Oliveri|||Paolo Guiddi|||Gabriella Pravettoni 202106 Research PMC Background During the COVID-19 pandemic, between March and May 2020, in Italy, people were asked to shelter in place and most had to put their life on hold, while news of the spread of the virus constantly were broadcasted. The change in habits and the potential exposure to a dangerous virus can be categorized as a catastrophic event, which are usually traumatic and therefore have psychological consequences for the people involved. Objective Assuming the COVID-19 pandemic as a possible traumatic event, this study aims to explore the contingent behavioural and psychological impact of COVID-19 spread and related lockdown on the Italian general population, through measuring anxiety and post-traumatic stress symptoms . Methods An ad hoc-survey was set up for the this exploratory research, including the standardized Italian versions of the Impact of Event Scale Revised (IES-R) and the Generalized Anxiety Scale (GAD-7), and ad hoc items concerning behavioural reactions due to the pandemic spread and related mass quarantine. Participants were recruited across convenient web-based and mobile app channels using a snowball sampling technique. Data was collected from March 25th to May 1st, 2020. Participants One-thousand one hundred and ninety-five individuals (851 women and 342 men) completed 60% or more of the survey and were considered for analyses. Mean age was 40?years (s.d.?=?14.948). Participants resided in 78 Italian provinces (out of 107 territorial divisions), with 25.7% residing in the Milan province and 9.2% from the Monza and Brianza provinces, closest to the epicentre of the Italian outbreak. Results During the worst months of the first wave of the Pandemic, the Italian population suffered high level of distress (GAD-7?m?=?6.89, s.d. = 5.08; IER-R mean score?=?27.86, s.d. 17.46), respectively indicating mild presence of anxiety symptoms, and high levels of PTSD symptoms. Gender seems to be a discriminating variable with women scoring significantly higher than man, both for anxiety symptoms (H (1)?=?82.91, p <?.001) and all dimensions of PTSD symptoms (intrusion H (1)?=?71.23, p <?.001, avoidance H (1)?=?61.28, p?<?.001), and hyperarousal (H (1)?=?67.348, p?<?.001). People from Generations Y and Z show to be at higher risk of developing PTSD (V?=?.746, F (3,1041) =1017.19, p =?.001) and GAD symptoms (F (3,1041)?=?5.113, p =?.002) than older generations. Conclusions Gender and generation appeared to be the most consistent risk factor for higher levels of generalized anxiety and PTSD symptoms in the current pandemic. Other variables ? such as information seeking behaviours, parental and marriage status, chronic conditions ? yielded less consistent evidence. Results indicate the need of including psychological interventions as a standard tool during the emergency management of a catastrophic events such as a pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8206880/ 28 2474-7629 BMC Public Health London : BioMed Central
5902 114788 MERS PPE Term PPE abstract 개인보호장비 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
5903 114788 MERS prognosis Term prognosis abstract 예후 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
5904 114788 MERS protocol Term protocol abstract 프로토콜 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
11109 114788 MERS outcomes Term outcomes abstract 결과 202823 https://doi.org/10.1001/jamaoncol.2020.6178 Analyses of Risk, Racial Disparity, and Outcomes Among US Patients With Cancer and COVID-19 Infection QuanQiu Wang|||Nathan A Berger|||Rong Xu 202102 pubmed {{ Importance: }} Patients with specific cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19) and its severe outcomes. At present, limited data are available on the risk, racial disparity, and outcomes for COVID-19 illness in patients with cancer. !!{{ Objectives: }} To investigate how patients with specific types of cancer are at risk for COVID-19 infection and its adverse outcomes and whether there are cancer-specific race disparities for COVID-19 infection. !!{{ Design, setting, and participants: }} This retrospective case-control analysis of patient electronic health records included 73.4 million patients from 360 hospitals and 317 000 clinicians across 50 US states to August 14, 2020. The odds of COVID-19 infections for 13 common cancer types and adverse outcomes were assessed. !!{{ Exposures: }} The exposure groups were patients diagnosed with a specific cancer, whereas the unexposed groups were patients without the specific cancer. !!{{ Main outcomes and measures: }} The adjusted odds ratio (aOR) and 95% CI were estimated using the Cochran-Mantel-Haenszel test for the risk of COVID-19 infection. !!{{ Results: }} Among the 73.4 million patients included in the analysis (53.6% female), 2 523 920 had at least 1 of the 13 common cancers diagnosed (all cancer diagnosed within or before the last year), and 273 140 had recent cancer (cancer diagnosed within the last year). Among 16 570 patients diagnosed with COVID-19, 1200 had a cancer diagnosis and 690 had a recent cancer diagnosis of at least 1 of the 13 common cancers. Those with recent cancer diagnosis were at significantly increased risk for COVID-19 infection (aOR, 7.14 [95% CI, 6.91-7.39]; P &lt; .001), with the strongest association for recently diagnosed leukemia (aOR, 12.16 [95% CI, 11.03-13.40]; P &lt; .001), non-Hodgkin lymphoma (aOR, 8.54 [95% CI, 7.80-9.36]; P &lt; .001), and lung cancer (aOR, 7.66 [95% CI, 7.07-8.29]; P &lt; .001) and weakest for thyroid cancer (aOR, 3.10 [95% CI, 2.47-3.87]; P &lt; .001). Among patients with recent cancer diagnosis, African Americans had a significantly higher risk for COVID-19 infection than White patients; this racial disparity was largest for breast cancer (aOR, 5.44 [95% CI, 4.69-6.31]; P &lt; .001), followed by prostate cancer (aOR, 5.10 [95% CI, 4.34-5.98]; P &lt; .001), colorectal cancer (aOR, 3.30 [95% CI, 2.55-4.26]; P &lt; .001), and lung cancer (aOR, 2.53 [95% CI, 2.10-3.06]; P &lt; .001). Patients with cancer and COVID-19 had significantly worse outcomes (hospitalization, 47.46%; death, 14.93%) than patients with COVID-19 without cancer (hospitalization, 24.26%; death, 5.26%) (P &lt; .001) and patients with cancer without COVID-19 (hospitalization, 12.39%; death, 4.03%) (P &lt; .001). !!{{ Conclusions and relevance: }} In this case-control study, patients with cancer were at significantly increased risk for COVID-19 infection and worse outcomes, which was further exacerbated among African Americans. These findings highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7729584/ 689 2374-2437 JAMA Oncology Chicago, Il : American Medical Association
4821 114788 MERS Day Term Day abstract 43303 https://doi.org/10.4102/phcfm.v12i1.2624 Turnaround times ? the Achilles’ heel of community screening and testing in Cape Town, South Africa: A short report James D. Porter|||Robert Mash|||Wolfgang Preiser 202010 Short Report PMC Early in the course of the coronavirus infection disease 2019 (COVID-19) pandemic in South Africa, the Department of Health implemented a policy of community screening and testing (CST). This was based on a community-orientated primary care approach and was a key strategy in limiting the spread of the pandemic, but it struggled with long turnaround times (TATs) for the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) reverse transcriptase polymerase chain reaction test. The local experience at Symphony Way Community Day Centre (Delft, Cape Town), highlighted these challenges. The first positive tests had a median TAT of 4.5 days, peaking at 29 days in mid-May 2020. Issues that contributed to long TATs were unavailability of viral transport medium, sample delivery and storage difficulties, staffing problems, scarcity of testing supplies and other samples prioritised over CST samples. At Symphony Way, many patients who tested COVID-19 positive had abandoned their self-isolation because of the delay in results. Employers were unhappy with prolonged sick leave whilst waiting for results and patients were concerned about not getting paid or job loss. The CST policy relies on a rapid TAT to be successful. Once the TAT is delayed, the process of contacting patients, and tracing and quarantining contacts becomes ineffective. With hindsight, other countries’ difficulties in upscaling testing should have served as warning. Community screening and testing was scaled back from 18 May 2020, and testing policy was changed to only include high-risk patients from 29 May 2020. The delayed TATs meant that the CST policy had no beneficial impact at local level. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7564763/ 562 2071-2928 African Journal of Primary Health Care & Family Me Tygervalley, South Africa : OpenJournals Pub.
5899 114788 MERS pathway Term pathway abstract 경로 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
5894 114788 MERS multidisciplinary discussion Term multidisciplinary discussion abstract 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
3705 114788 MERS cumulative Term cumulative abstract 26009 https://doi.org/10.1001/jama.2021.18178 Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial Writing Committee for the REMAP-CAP Investigators|||Lise J Estcourt|||Alexis F Turgeon|||Zoe K McQuilten|||Bryan J McVerry|||Farah Al-Beidh|||Djillali Annane|||Yaseen M Arabi|||Donald M Arnold|||Abigail Beane|||Philippe B?gin|||Wilma van Bentum-Puijk|||Lindsay R Berry|||Zahra Bhimani|||Janet E Birchall|||Marc J M Bonten|||Charlotte A Bradbury|||Frank M Brunkhorst|||Meredith Buxton|||Jeannie L Callum|||Micha?l Chass?|||Allen C Cheng|||Matthew E Cove|||James Daly|||Lennie Derde|||Michelle A Detry|||Menno De Jong|||Amy Evans|||Dean A Fergusson|||Matthew Fish|||Mark Fitzgerald|||Claire Foley|||Herman Goossens|||Anthony C Gordon|||Iain B Gosbell|||Cameron Green|||Rashan Haniffa|||Heli Harvala|||Alisa M Higgins|||Thomas E Hills|||Veronica C Hoad|||Christopher Horvat|||David T Huang|||Cara L Hudson|||Nao Ichihara|||Emma Laing|||Abigail A Lamikanra|||Fran?ois Lamontagne|||Patrick R Lawler|||Kelsey Linstrum|||Edward Litton|||Elizabeth Lorenzi|||Sheila MacLennan|||John Marshall|||Daniel F McAuley|||John F McDyer|||Anna McGlothlin|||Shay McGuinness|||Gail Miflin|||Stephanie Montgomery|||Paul R Mouncey|||Srinivas Murthy|||Alistair Nichol|||Rachael Parke|||Jane C Parker|||Nicole Priddee|||Damian F J Purcell|||Luis F Reyes|||Peter Richardson|||Nancy Robitaille|||Kathryn M Rowan|||Jennifer Rynne|||Hiroki Saito|||Marlene Santos|||Christina T Saunders|||Ary Serpa Neto|||Christopher W Seymour|||Jon A Silversides|||Alan A Tinmouth|||Darrell J Triulzi|||Anne M Turner|||Frank van de Veerdonk|||Timothy S Walsh|||Erica M Wood|||Scott Berry|||Roger J Lewis|||David K Menon|||Colin McArthur|||Ryan Zarychanski|||Derek C Angus|||Steve A Webb|||David J Roberts|||Manu Shankar-Hari 202111 Trial PMC {{{ Abstract }}} !!{{ Importance: }} The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. !!{{ Objective: }} To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. !!{{ Design, setting, and participants: }} The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. !!{{ Interventions: }} The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). !!{{ Main outcomes and measures: }} The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority &gt;99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility &gt;95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. !!{{ Results: }} Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR &lt;1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. !!{{ Conclusions and relevance: }} Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. !!{{ Trial registration: }} ClinicalTrials.gov Identifier: NCT02735707 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8491132/ 1093 0098-7484 JAMA Chicago : American Medical Association
5912 114788 MERS Society Term Society abstract 사회 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
5913 114788 MERS Specific Term Specific abstract 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
5915 114788 MERS structures Term structures abstract 구조체 51972 https://doi.org/10.1007/s13304-020-00921-4 Surgical management of oncologic patient during and after the COVID-19 outbreak: practical recommendations from the Italian society of Surgical Oncology 202011 Original Article PMC The recent outbreak of COVID-19 in Italy caused a limitation of the resources of the health system, which necessarily led to their rationalization in the critical phase (phase 1) and a reorganization of the system in the following phase (phase 2). The Italian Society of Oncological Surgery?SICO has drafted these practical recommendations, calibrated on the most recent scientific literature and taking into account current health regulations and common sense. Surgical activity during phase 1 and 2 should follow a dynamic model, considering architectural structures, hospital mission, organizational models. Surgical delay should not affect oncological prognosis. However, COVID-19-positive cancer patients should be postponed until the infection is cured. The patients to consider more carefully before delaying surgery are those who have completed neoadjuvant therapy, patients with high biological aggressiveness tumors or without therapeutic alternatives. The multidisciplinary discussions are fundamental for sharing clinical decisions; videoconference meetings are preferable and use of telemedicine for follow-up is recommended. Especially in phase 1, maximum effort must be made to reduce the spread of the pandemic. Prefer intra-corporeal rather than open anastomosis during laparoscopy and mechanical rather than hand-sewn anastomosis in open surgery. Consider PPE for caregivers during stoma management. Minimal invasive surgery is not discouraged, because there is little evidence for augmented risk. Specific procedures have to be followed and use of energy devices has to be limited. Training programs with COVID-19?+?patients are not recommended. All staff in OR should be trained with specific courses on specific PPE use. Differentiate recommendations are presented for every district cancer. Surgical oncology during phase 2 should be guaranteed by individual and distinct protocols and pathways between cancer patients and COVID-19?+?patients with resources specifically addressed to the two distinct kind of patients to limit diagnostic/therapeutic interferences or slowdowns. These recommendations are based on currently available evidence about management of oncologic patients during COVID-19 pandemic, were endorsed by the SICO Executive Board, and are considered suitable for nationwide diffusion. They will be subject to updates and revisions in case of new and relevant scientific acquisitions. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7660129/ 2072 2038-131X Updates in surgery Milano : Springer-Verlag Italia.
11112 114788 MERS patients with cancer Patient patients with cancer abstract 202823 https://doi.org/10.1001/jamaoncol.2020.6178 Analyses of Risk, Racial Disparity, and Outcomes Among US Patients With Cancer and COVID-19 Infection QuanQiu Wang|||Nathan A Berger|||Rong Xu 202102 pubmed {{ Importance: }} Patients with specific cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19) and its severe outcomes. At present, limited data are available on the risk, racial disparity, and outcomes for COVID-19 illness in patients with cancer. !!{{ Objectives: }} To investigate how patients with specific types of cancer are at risk for COVID-19 infection and its adverse outcomes and whether there are cancer-specific race disparities for COVID-19 infection. !!{{ Design, setting, and participants: }} This retrospective case-control analysis of patient electronic health records included 73.4 million patients from 360 hospitals and 317 000 clinicians across 50 US states to August 14, 2020. The odds of COVID-19 infections for 13 common cancer types and adverse outcomes were assessed. !!{{ Exposures: }} The exposure groups were patients diagnosed with a specific cancer, whereas the unexposed groups were patients without the specific cancer. !!{{ Main outcomes and measures: }} The adjusted odds ratio (aOR) and 95% CI were estimated using the Cochran-Mantel-Haenszel test for the risk of COVID-19 infection. !!{{ Results: }} Among the 73.4 million patients included in the analysis (53.6% female), 2 523 920 had at least 1 of the 13 common cancers diagnosed (all cancer diagnosed within or before the last year), and 273 140 had recent cancer (cancer diagnosed within the last year). Among 16 570 patients diagnosed with COVID-19, 1200 had a cancer diagnosis and 690 had a recent cancer diagnosis of at least 1 of the 13 common cancers. Those with recent cancer diagnosis were at significantly increased risk for COVID-19 infection (aOR, 7.14 [95% CI, 6.91-7.39]; P &lt; .001), with the strongest association for recently diagnosed leukemia (aOR, 12.16 [95% CI, 11.03-13.40]; P &lt; .001), non-Hodgkin lymphoma (aOR, 8.54 [95% CI, 7.80-9.36]; P &lt; .001), and lung cancer (aOR, 7.66 [95% CI, 7.07-8.29]; P &lt; .001) and weakest for thyroid cancer (aOR, 3.10 [95% CI, 2.47-3.87]; P &lt; .001). Among patients with recent cancer diagnosis, African Americans had a significantly higher risk for COVID-19 infection than White patients; this racial disparity was largest for breast cancer (aOR, 5.44 [95% CI, 4.69-6.31]; P &lt; .001), followed by prostate cancer (aOR, 5.10 [95% CI, 4.34-5.98]; P &lt; .001), colorectal cancer (aOR, 3.30 [95% CI, 2.55-4.26]; P &lt; .001), and lung cancer (aOR, 2.53 [95% CI, 2.10-3.06]; P &lt; .001). Patients with cancer and COVID-19 had significantly worse outcomes (hospitalization, 47.46%; death, 14.93%) than patients with COVID-19 without cancer (hospitalization, 24.26%; death, 5.26%) (P &lt; .001) and patients with cancer without COVID-19 (hospitalization, 12.39%; death, 4.03%) (P &lt; .001). !!{{ Conclusions and relevance: }} In this case-control study, patients with cancer were at significantly increased risk for COVID-19 infection and worse outcomes, which was further exacerbated among African Americans. These findings highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7729584/ 689 2374-2437 JAMA Oncology Chicago, Il : American Medical Association
7552 114788 MERS disease Disease disease abstract 질병 71946 https://doi.org/10.3389/fpubh.2021.614789 Expected Impacts of COVID-19: Considering Resource-Limited Countries and Vulnerable Population Tigist Gashaw|||Bisrat Hagos|||Mekonnen Sisay 202105 Public Health PMC Coronavirus disease in 2019 emerged in Wuhan, Hubei Province, China, in December 2019. After a month, it was declared a global threat to public health. The effects of the pandemic could be socio-economic, undermining the health system and risking livelihoods. Vulnerability to this infection has been associated with underlying comorbidities such as hypertension, diabetes, coronary heart disease, chronic respiratory diseases, cancer, and compromised immune systems. Co-morbidity has been common to the elderly, the disabled, and the homeless. In addition, more severe coronavirus disease outcomes have been reported in older males than females. Nonetheless, multiple variables are related to the concept of cultural gender that should be taken into account as women in more affected sectors are economically disadvantageous and over-represented. Similarly, although children are not the face of this pandemic, calamity has a profound effect on their welfare, especially for those living in poor and inconvenient situations. Moreover, the economic influence could be profound and universal when viewed through a migration lens as it is exacerbating xenophobic and discriminatory treatment. Protection measures to mitigate the outbreak of a pandemic, such as social distancing, may reduce social support for certain categories relied on for their day-to-day activities. The mental health of people would definitely be affected by the additional psychosocial burden of the pandemic, particularly in vulnerable groups. Integrated approaches are therefore mandatory to assist these groups and contain the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8131657/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
11121 114788 MERS significantly higher Action significantly higher abstract 202823 https://doi.org/10.1001/jamaoncol.2020.6178 Analyses of Risk, Racial Disparity, and Outcomes Among US Patients With Cancer and COVID-19 Infection QuanQiu Wang|||Nathan A Berger|||Rong Xu 202102 pubmed {{ Importance: }} Patients with specific cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19) and its severe outcomes. At present, limited data are available on the risk, racial disparity, and outcomes for COVID-19 illness in patients with cancer. !!{{ Objectives: }} To investigate how patients with specific types of cancer are at risk for COVID-19 infection and its adverse outcomes and whether there are cancer-specific race disparities for COVID-19 infection. !!{{ Design, setting, and participants: }} This retrospective case-control analysis of patient electronic health records included 73.4 million patients from 360 hospitals and 317 000 clinicians across 50 US states to August 14, 2020. The odds of COVID-19 infections for 13 common cancer types and adverse outcomes were assessed. !!{{ Exposures: }} The exposure groups were patients diagnosed with a specific cancer, whereas the unexposed groups were patients without the specific cancer. !!{{ Main outcomes and measures: }} The adjusted odds ratio (aOR) and 95% CI were estimated using the Cochran-Mantel-Haenszel test for the risk of COVID-19 infection. !!{{ Results: }} Among the 73.4 million patients included in the analysis (53.6% female), 2 523 920 had at least 1 of the 13 common cancers diagnosed (all cancer diagnosed within or before the last year), and 273 140 had recent cancer (cancer diagnosed within the last year). Among 16 570 patients diagnosed with COVID-19, 1200 had a cancer diagnosis and 690 had a recent cancer diagnosis of at least 1 of the 13 common cancers. Those with recent cancer diagnosis were at significantly increased risk for COVID-19 infection (aOR, 7.14 [95% CI, 6.91-7.39]; P &lt; .001), with the strongest association for recently diagnosed leukemia (aOR, 12.16 [95% CI, 11.03-13.40]; P &lt; .001), non-Hodgkin lymphoma (aOR, 8.54 [95% CI, 7.80-9.36]; P &lt; .001), and lung cancer (aOR, 7.66 [95% CI, 7.07-8.29]; P &lt; .001) and weakest for thyroid cancer (aOR, 3.10 [95% CI, 2.47-3.87]; P &lt; .001). Among patients with recent cancer diagnosis, African Americans had a significantly higher risk for COVID-19 infection than White patients; this racial disparity was largest for breast cancer (aOR, 5.44 [95% CI, 4.69-6.31]; P &lt; .001), followed by prostate cancer (aOR, 5.10 [95% CI, 4.34-5.98]; P &lt; .001), colorectal cancer (aOR, 3.30 [95% CI, 2.55-4.26]; P &lt; .001), and lung cancer (aOR, 2.53 [95% CI, 2.10-3.06]; P &lt; .001). Patients with cancer and COVID-19 had significantly worse outcomes (hospitalization, 47.46%; death, 14.93%) than patients with COVID-19 without cancer (hospitalization, 24.26%; death, 5.26%) (P &lt; .001) and patients with cancer without COVID-19 (hospitalization, 12.39%; death, 4.03%) (P &lt; .001). !!{{ Conclusions and relevance: }} In this case-control study, patients with cancer were at significantly increased risk for COVID-19 infection and worse outcomes, which was further exacerbated among African Americans. These findings highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7729584/ 689 2374-2437 JAMA Oncology Chicago, Il : American Medical Association
7542 114788 MERS assist Term assist abstract 71946 https://doi.org/10.3389/fpubh.2021.614789 Expected Impacts of COVID-19: Considering Resource-Limited Countries and Vulnerable Population Tigist Gashaw|||Bisrat Hagos|||Mekonnen Sisay 202105 Public Health PMC Coronavirus disease in 2019 emerged in Wuhan, Hubei Province, China, in December 2019. After a month, it was declared a global threat to public health. The effects of the pandemic could be socio-economic, undermining the health system and risking livelihoods. Vulnerability to this infection has been associated with underlying comorbidities such as hypertension, diabetes, coronary heart disease, chronic respiratory diseases, cancer, and compromised immune systems. Co-morbidity has been common to the elderly, the disabled, and the homeless. In addition, more severe coronavirus disease outcomes have been reported in older males than females. Nonetheless, multiple variables are related to the concept of cultural gender that should be taken into account as women in more affected sectors are economically disadvantageous and over-represented. Similarly, although children are not the face of this pandemic, calamity has a profound effect on their welfare, especially for those living in poor and inconvenient situations. Moreover, the economic influence could be profound and universal when viewed through a migration lens as it is exacerbating xenophobic and discriminatory treatment. Protection measures to mitigate the outbreak of a pandemic, such as social distancing, may reduce social support for certain categories relied on for their day-to-day activities. The mental health of people would definitely be affected by the additional psychosocial burden of the pandemic, particularly in vulnerable groups. Integrated approaches are therefore mandatory to assist these groups and contain the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8131657/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
9274 114788 MERS surveillance system Term surveillance system abstract 187952 https://doi.org/10.1038/s41577-020-0338-x The non-specific and sex-differential effects of vaccines Peter Aaby|||Christine Stabell Benn|||Katie L. Flanagan|||Sabra L. Klein|||Tobias R. Kollmann|||David J. Lynn|||Frank Shann 202005 PMC The textbook view of vaccination is that it functions to induce immune memory of the specific pathogen components of the vaccine, leading to a quantitatively and qualitatively better response if the host is exposed to infection with the same pathogen. However, evidence accumulated over the past few decades increasingly suggests that vaccines can also have non-specific effects on unrelated infections and diseases, with important implications for childhood mortality particularly in low-income settings. Furthermore, many of these non-specific effects, as well as the pathogen-specific effects, of vaccines show differences between the sexes. Here, members of the Optimmunize consortium discuss the evidence for and potential mechanisms of non-specific and sex-differential effects of vaccines, as well as their potential policy implications. Given that the non-specific effects of some vaccines are now being tested for their ability to protect against COVID-19, the authors also comment on the broader implications of these trials. In this Viewpoint article, members of the Optimmunize consortium discuss the evidence for non-specific and sex-differential effects of vaccines and how this information might inform vaccine design and policy, including in relation to the COVID-19 pandemic. The contributors Peter Aaby was trained as an anthropologist but has built a large health surveillance system in Guinea-Bissau since 1978, focusing on the high levels of child mortality there. Crowding and intensive exposure to measles were key determinants of child mortality. This led to vaccine research and the discovery of the non-specific effects of measles vaccine. Christine Stabell Benn is a professor in global health at the University of Southern Denmark. She conducts epidemiological and immunological studies of vaccines and vitamin A, with a focus on their real-life effects on overall health in Africa and Denmark. She formulated the hypothesis that these health interventions with immunomodulatory effects interact, often in a sex-differential manner. Katie L. Flanagan is Director of Infectious Diseases for north/north-west Tasmania, an adjunct professor at the University of Tasmania and RMIT University and an adjunct associate professor at Monash University. She is Honorary Secretary of the Australasian Society for Infectious Diseases (ASID), Chair of the ASID Vaccination Special Interest Group and a member of the Australian Technical Advisory Group on Immunisation. Her current research focuses on using systems vaccinology to study the sex-differential and non-targeted effects of vaccines. Sabra L. Klein is a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. She is an expert on sex and gender differences in immune responses and susceptibility to infection. She is the immediate past president of the Organization for the Study of Sex Differences, a principal investigator of the Johns Hopkins Specialized Center for Research Excellence in sex and age differences in immunity to influenza and a co-director of the Johns Hopkins Center for Women’s Health, Sex, and Gender Research. Tobias R. Kollmann is a paediatric infectious disease clinician and systems vaccinologist at Telethon Kids Institute and Perth Children’s Hospital in Perth, Australia. His expertise centres on newborn infectious diseases, immune ontogeny and early-life vaccine responses, using cutting-edge technology and analytics to extract the most information out of the typically small biological samples obtainable in early life. David J. Lynn is Director of the Computational and Systems Biology Program and an EMBL Australia group leader at the South Australian Health and Medical Research Institute. He is also a professor at the Flinders University College of Medicine and Public Health. He leads a research programme in systems immunology, investigating how pathogenic and commensal microorganisms modulate the immune system in different contexts, including vaccination. Frank Shann worked as a paediatrician in Papua New Guinea and then for 20 years was Director of Intensive Care at the Royal Children’s Hospital in Melbourne, Australia. He is a professorial fellow in the Department of Paediatrics, University of Melbourne, engaged in research on the non-specific effects of vaccines. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7252419/ 1152 1474-1733 Nature reviews. Immunology London, UK : Nature Pub. Group
7577 114788 MERS Population Term population title 개체군 71946 https://doi.org/10.3389/fpubh.2021.614789 Expected Impacts of COVID-19: Considering Resource-Limited Countries and Vulnerable Population Tigist Gashaw|||Bisrat Hagos|||Mekonnen Sisay 202105 Public Health PMC Coronavirus disease in 2019 emerged in Wuhan, Hubei Province, China, in December 2019. After a month, it was declared a global threat to public health. The effects of the pandemic could be socio-economic, undermining the health system and risking livelihoods. Vulnerability to this infection has been associated with underlying comorbidities such as hypertension, diabetes, coronary heart disease, chronic respiratory diseases, cancer, and compromised immune systems. Co-morbidity has been common to the elderly, the disabled, and the homeless. In addition, more severe coronavirus disease outcomes have been reported in older males than females. Nonetheless, multiple variables are related to the concept of cultural gender that should be taken into account as women in more affected sectors are economically disadvantageous and over-represented. Similarly, although children are not the face of this pandemic, calamity has a profound effect on their welfare, especially for those living in poor and inconvenient situations. Moreover, the economic influence could be profound and universal when viewed through a migration lens as it is exacerbating xenophobic and discriminatory treatment. Protection measures to mitigate the outbreak of a pandemic, such as social distancing, may reduce social support for certain categories relied on for their day-to-day activities. The mental health of people would definitely be affected by the additional psychosocial burden of the pandemic, particularly in vulnerable groups. Integrated approaches are therefore mandatory to assist these groups and contain the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8131657/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
9205 114788 MERS Denmark Term Denmark abstract 덴마크왕국 187952 https://doi.org/10.1038/s41577-020-0338-x The non-specific and sex-differential effects of vaccines Peter Aaby|||Christine Stabell Benn|||Katie L. Flanagan|||Sabra L. Klein|||Tobias R. Kollmann|||David J. Lynn|||Frank Shann 202005 PMC The textbook view of vaccination is that it functions to induce immune memory of the specific pathogen components of the vaccine, leading to a quantitatively and qualitatively better response if the host is exposed to infection with the same pathogen. However, evidence accumulated over the past few decades increasingly suggests that vaccines can also have non-specific effects on unrelated infections and diseases, with important implications for childhood mortality particularly in low-income settings. Furthermore, many of these non-specific effects, as well as the pathogen-specific effects, of vaccines show differences between the sexes. Here, members of the Optimmunize consortium discuss the evidence for and potential mechanisms of non-specific and sex-differential effects of vaccines, as well as their potential policy implications. Given that the non-specific effects of some vaccines are now being tested for their ability to protect against COVID-19, the authors also comment on the broader implications of these trials. In this Viewpoint article, members of the Optimmunize consortium discuss the evidence for non-specific and sex-differential effects of vaccines and how this information might inform vaccine design and policy, including in relation to the COVID-19 pandemic. The contributors Peter Aaby was trained as an anthropologist but has built a large health surveillance system in Guinea-Bissau since 1978, focusing on the high levels of child mortality there. Crowding and intensive exposure to measles were key determinants of child mortality. This led to vaccine research and the discovery of the non-specific effects of measles vaccine. Christine Stabell Benn is a professor in global health at the University of Southern Denmark. She conducts epidemiological and immunological studies of vaccines and vitamin A, with a focus on their real-life effects on overall health in Africa and Denmark. She formulated the hypothesis that these health interventions with immunomodulatory effects interact, often in a sex-differential manner. Katie L. Flanagan is Director of Infectious Diseases for north/north-west Tasmania, an adjunct professor at the University of Tasmania and RMIT University and an adjunct associate professor at Monash University. She is Honorary Secretary of the Australasian Society for Infectious Diseases (ASID), Chair of the ASID Vaccination Special Interest Group and a member of the Australian Technical Advisory Group on Immunisation. Her current research focuses on using systems vaccinology to study the sex-differential and non-targeted effects of vaccines. Sabra L. Klein is a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. She is an expert on sex and gender differences in immune responses and susceptibility to infection. She is the immediate past president of the Organization for the Study of Sex Differences, a principal investigator of the Johns Hopkins Specialized Center for Research Excellence in sex and age differences in immunity to influenza and a co-director of the Johns Hopkins Center for Women’s Health, Sex, and Gender Research. Tobias R. Kollmann is a paediatric infectious disease clinician and systems vaccinologist at Telethon Kids Institute and Perth Children’s Hospital in Perth, Australia. His expertise centres on newborn infectious diseases, immune ontogeny and early-life vaccine responses, using cutting-edge technology and analytics to extract the most information out of the typically small biological samples obtainable in early life. David J. Lynn is Director of the Computational and Systems Biology Program and an EMBL Australia group leader at the South Australian Health and Medical Research Institute. He is also a professor at the Flinders University College of Medicine and Public Health. He leads a research programme in systems immunology, investigating how pathogenic and commensal microorganisms modulate the immune system in different contexts, including vaccination. Frank Shann worked as a paediatrician in Papua New Guinea and then for 20 years was Director of Intensive Care at the Royal Children’s Hospital in Melbourne, Australia. He is a professorial fellow in the Department of Paediatrics, University of Melbourne, engaged in research on the non-specific effects of vaccines. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7252419/ 1152 1474-1733 Nature reviews. Immunology London, UK : Nature Pub. Group
7170 114788 MERS Crisis Term Crisis title 위기 65375 https://doi.org/10.6061/clinics/2020/e1895 The Importance of Scientific Publications in Times of Pandemic Crisis Luiz Felipe Pinho Moreira 202004 Editorial PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7134545/ 194 1807-5932 Clinics [New York] : Elsevier.
7262 114788 MERS PEDV strain Term PEDV strain author 67022 https://doi.org/10.3201/eid2014.140908 Third Strain of Porcine Epidemic Diarrhea Virus, United States Douglas Marthaler|||Laura Bruner|||James Collins|||Kurt Rossow 201412 Expedited PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/4257813/ 4 1080-6040 Emerging Infectious Diseases Atlanta, GA : National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC) 3.67000
7268 114788 MERS United States Term United States author 미국 67022 https://doi.org/10.3201/eid2014.140908 Third Strain of Porcine Epidemic Diarrhea Virus, United States Douglas Marthaler|||Laura Bruner|||James Collins|||Kurt Rossow 201412 Expedited PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/4257813/ 4 1080-6040 Emerging Infectious Diseases Atlanta, GA : National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC) 3.67000
7546 114788 MERS chronic respiratory diseases Disease chronic respiratory diseases abstract 만성호흡기질환 71946 https://doi.org/10.3389/fpubh.2021.614789 Expected Impacts of COVID-19: Considering Resource-Limited Countries and Vulnerable Population Tigist Gashaw|||Bisrat Hagos|||Mekonnen Sisay 202105 Public Health PMC Coronavirus disease in 2019 emerged in Wuhan, Hubei Province, China, in December 2019. After a month, it was declared a global threat to public health. The effects of the pandemic could be socio-economic, undermining the health system and risking livelihoods. Vulnerability to this infection has been associated with underlying comorbidities such as hypertension, diabetes, coronary heart disease, chronic respiratory diseases, cancer, and compromised immune systems. Co-morbidity has been common to the elderly, the disabled, and the homeless. In addition, more severe coronavirus disease outcomes have been reported in older males than females. Nonetheless, multiple variables are related to the concept of cultural gender that should be taken into account as women in more affected sectors are economically disadvantageous and over-represented. Similarly, although children are not the face of this pandemic, calamity has a profound effect on their welfare, especially for those living in poor and inconvenient situations. Moreover, the economic influence could be profound and universal when viewed through a migration lens as it is exacerbating xenophobic and discriminatory treatment. Protection measures to mitigate the outbreak of a pandemic, such as social distancing, may reduce social support for certain categories relied on for their day-to-day activities. The mental health of people would definitely be affected by the additional psychosocial burden of the pandemic, particularly in vulnerable groups. Integrated approaches are therefore mandatory to assist these groups and contain the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8131657/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
7588 114788 MERS vulnerable Term Vulnerable author,title 71946 https://doi.org/10.3389/fpubh.2021.614789 Expected Impacts of COVID-19: Considering Resource-Limited Countries and Vulnerable Population Tigist Gashaw|||Bisrat Hagos|||Mekonnen Sisay 202105 Public Health PMC Coronavirus disease in 2019 emerged in Wuhan, Hubei Province, China, in December 2019. After a month, it was declared a global threat to public health. The effects of the pandemic could be socio-economic, undermining the health system and risking livelihoods. Vulnerability to this infection has been associated with underlying comorbidities such as hypertension, diabetes, coronary heart disease, chronic respiratory diseases, cancer, and compromised immune systems. Co-morbidity has been common to the elderly, the disabled, and the homeless. In addition, more severe coronavirus disease outcomes have been reported in older males than females. Nonetheless, multiple variables are related to the concept of cultural gender that should be taken into account as women in more affected sectors are economically disadvantageous and over-represented. Similarly, although children are not the face of this pandemic, calamity has a profound effect on their welfare, especially for those living in poor and inconvenient situations. Moreover, the economic influence could be profound and universal when viewed through a migration lens as it is exacerbating xenophobic and discriminatory treatment. Protection measures to mitigate the outbreak of a pandemic, such as social distancing, may reduce social support for certain categories relied on for their day-to-day activities. The mental health of people would definitely be affected by the additional psychosocial burden of the pandemic, particularly in vulnerable groups. Integrated approaches are therefore mandatory to assist these groups and contain the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8131657/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
9253 114788 MERS non-specific Term non-specific title,abstract 비특정 187952 https://doi.org/10.1038/s41577-020-0338-x The non-specific and sex-differential effects of vaccines Peter Aaby|||Christine Stabell Benn|||Katie L. Flanagan|||Sabra L. Klein|||Tobias R. Kollmann|||David J. Lynn|||Frank Shann 202005 PMC The textbook view of vaccination is that it functions to induce immune memory of the specific pathogen components of the vaccine, leading to a quantitatively and qualitatively better response if the host is exposed to infection with the same pathogen. However, evidence accumulated over the past few decades increasingly suggests that vaccines can also have non-specific effects on unrelated infections and diseases, with important implications for childhood mortality particularly in low-income settings. Furthermore, many of these non-specific effects, as well as the pathogen-specific effects, of vaccines show differences between the sexes. Here, members of the Optimmunize consortium discuss the evidence for and potential mechanisms of non-specific and sex-differential effects of vaccines, as well as their potential policy implications. Given that the non-specific effects of some vaccines are now being tested for their ability to protect against COVID-19, the authors also comment on the broader implications of these trials. In this Viewpoint article, members of the Optimmunize consortium discuss the evidence for non-specific and sex-differential effects of vaccines and how this information might inform vaccine design and policy, including in relation to the COVID-19 pandemic. The contributors Peter Aaby was trained as an anthropologist but has built a large health surveillance system in Guinea-Bissau since 1978, focusing on the high levels of child mortality there. Crowding and intensive exposure to measles were key determinants of child mortality. This led to vaccine research and the discovery of the non-specific effects of measles vaccine. Christine Stabell Benn is a professor in global health at the University of Southern Denmark. She conducts epidemiological and immunological studies of vaccines and vitamin A, with a focus on their real-life effects on overall health in Africa and Denmark. She formulated the hypothesis that these health interventions with immunomodulatory effects interact, often in a sex-differential manner. Katie L. Flanagan is Director of Infectious Diseases for north/north-west Tasmania, an adjunct professor at the University of Tasmania and RMIT University and an adjunct associate professor at Monash University. She is Honorary Secretary of the Australasian Society for Infectious Diseases (ASID), Chair of the ASID Vaccination Special Interest Group and a member of the Australian Technical Advisory Group on Immunisation. Her current research focuses on using systems vaccinology to study the sex-differential and non-targeted effects of vaccines. Sabra L. Klein is a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. She is an expert on sex and gender differences in immune responses and susceptibility to infection. She is the immediate past president of the Organization for the Study of Sex Differences, a principal investigator of the Johns Hopkins Specialized Center for Research Excellence in sex and age differences in immunity to influenza and a co-director of the Johns Hopkins Center for Women’s Health, Sex, and Gender Research. Tobias R. Kollmann is a paediatric infectious disease clinician and systems vaccinologist at Telethon Kids Institute and Perth Children’s Hospital in Perth, Australia. His expertise centres on newborn infectious diseases, immune ontogeny and early-life vaccine responses, using cutting-edge technology and analytics to extract the most information out of the typically small biological samples obtainable in early life. David J. Lynn is Director of the Computational and Systems Biology Program and an EMBL Australia group leader at the South Australian Health and Medical Research Institute. He is also a professor at the Flinders University College of Medicine and Public Health. He leads a research programme in systems immunology, investigating how pathogenic and commensal microorganisms modulate the immune system in different contexts, including vaccination. Frank Shann worked as a paediatrician in Papua New Guinea and then for 20 years was Director of Intensive Care at the Royal Children’s Hospital in Melbourne, Australia. He is a professorial fellow in the Department of Paediatrics, University of Melbourne, engaged in research on the non-specific effects of vaccines. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7252419/ 1152 1474-1733 Nature reviews. Immunology London, UK : Nature Pub. Group
9881 114788 MERS susceptible Action susceptible abstract 192297 https://doi.org/10.1016/j.envres.2020.110603 On the concentration of SARS-CoV-2 in outdoor air and the interaction with pre-existing atmospheric particles Franco Belosi|||Marianna Conte|||Vorne Gianelle|||Gianni Santachiara|||Daniele Contini 202012 Article PMC The spread of SARS-CoV-2 by contact (direct or indirect) is widely accepted, but the relative importance of airborne transmission is still controversial. Probability of outdoor airborne transmission depends on several parameters, still rather uncertain: virus-laden aerosol concentrations, viability and lifetime, minimum dose necessary to transmit the disease. In this work, an estimate of outdoor concentrations in northern Italy (region Lombardia) was performed using a simple box model approach, based on an estimate of respiratory emissions, with a specific focus for the cities of Milan and Bergamo (Italy). In addition, the probability of interaction of virus-laden aerosol with pre-existing particles of different sizes was investigated. Results indicate very low (<1 RNA copy/m 3 ) average outdoor concentrations in public area, excluding crowded zones, even in the worst case scenario and assuming a number of infects up to 25% of population. On average, assuming a number of infects equal to 10% of the population, the time necessary to inspire a quantum (i.e. the dose of airborne droplet nuclei required to cause infection in 63% of susceptible persons) would be 31.5 days in Milan (range 2.7?91 days) and 51.2 days in Bergamo (range 4.4?149 days). Therefore, the probability of airborne transmission due to respiratory aerosol is very low in outdoor conditions, even if it could be more relevant for community indoor environments, in which further studies are necessary to investigate the potential risks. We theoretically examined if atmospheric particles can scavenge virus aerosol, through inertial impact, interception, and Brownian diffusion. The probability was very low. In addition, the probability of coagulation of virus-laden aerosol with pre-existing atmospheric particles resulted negligible for accumulation and coarse mode particles, but virus-laden aerosol could act as sink of ultrafine particles (around 0.01?μm in diameter). However, this will not change significantly the dynamics behaviour of the virus particle or its permanence time in atmosphere. Highlights ? Concentrations of SARS-CoV-2 in outdoor air were estimated using a box model. ? Probability of interactions with pre-existing aerosol particles was investigated. ? Average outdoor concentration was <1 RNA copy/m 3 even in the worst case scenario. ? Probability of outdoor airborne transmission was extremely low. ? Virus-laden aerosol could act as a sink of ultrafine particles. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7833947/ 1002 0013-9351 Environmental research Amsterdam : Elsevier.
9852 114788 MERS concentrations Term concentrations abstract 192297 https://doi.org/10.1016/j.envres.2020.110603 On the concentration of SARS-CoV-2 in outdoor air and the interaction with pre-existing atmospheric particles Franco Belosi|||Marianna Conte|||Vorne Gianelle|||Gianni Santachiara|||Daniele Contini 202012 Article PMC The spread of SARS-CoV-2 by contact (direct or indirect) is widely accepted, but the relative importance of airborne transmission is still controversial. Probability of outdoor airborne transmission depends on several parameters, still rather uncertain: virus-laden aerosol concentrations, viability and lifetime, minimum dose necessary to transmit the disease. In this work, an estimate of outdoor concentrations in northern Italy (region Lombardia) was performed using a simple box model approach, based on an estimate of respiratory emissions, with a specific focus for the cities of Milan and Bergamo (Italy). In addition, the probability of interaction of virus-laden aerosol with pre-existing particles of different sizes was investigated. Results indicate very low (<1 RNA copy/m 3 ) average outdoor concentrations in public area, excluding crowded zones, even in the worst case scenario and assuming a number of infects up to 25% of population. On average, assuming a number of infects equal to 10% of the population, the time necessary to inspire a quantum (i.e. the dose of airborne droplet nuclei required to cause infection in 63% of susceptible persons) would be 31.5 days in Milan (range 2.7?91 days) and 51.2 days in Bergamo (range 4.4?149 days). Therefore, the probability of airborne transmission due to respiratory aerosol is very low in outdoor conditions, even if it could be more relevant for community indoor environments, in which further studies are necessary to investigate the potential risks. We theoretically examined if atmospheric particles can scavenge virus aerosol, through inertial impact, interception, and Brownian diffusion. The probability was very low. In addition, the probability of coagulation of virus-laden aerosol with pre-existing atmospheric particles resulted negligible for accumulation and coarse mode particles, but virus-laden aerosol could act as sink of ultrafine particles (around 0.01?μm in diameter). However, this will not change significantly the dynamics behaviour of the virus particle or its permanence time in atmosphere. Highlights ? Concentrations of SARS-CoV-2 in outdoor air were estimated using a box model. ? Probability of interactions with pre-existing aerosol particles was investigated. ? Average outdoor concentration was <1 RNA copy/m 3 even in the worst case scenario. ? Probability of outdoor airborne transmission was extremely low. ? Virus-laden aerosol could act as a sink of ultrafine particles. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7833947/ 1002 0013-9351 Environmental research Amsterdam : Elsevier.
11085 114788 MERS colorectal cancer Disease colorectal cancer abstract 대장암 202823 https://doi.org/10.1001/jamaoncol.2020.6178 Analyses of Risk, Racial Disparity, and Outcomes Among US Patients With Cancer and COVID-19 Infection QuanQiu Wang|||Nathan A Berger|||Rong Xu 202102 pubmed {{ Importance: }} Patients with specific cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19) and its severe outcomes. At present, limited data are available on the risk, racial disparity, and outcomes for COVID-19 illness in patients with cancer. !!{{ Objectives: }} To investigate how patients with specific types of cancer are at risk for COVID-19 infection and its adverse outcomes and whether there are cancer-specific race disparities for COVID-19 infection. !!{{ Design, setting, and participants: }} This retrospective case-control analysis of patient electronic health records included 73.4 million patients from 360 hospitals and 317 000 clinicians across 50 US states to August 14, 2020. The odds of COVID-19 infections for 13 common cancer types and adverse outcomes were assessed. !!{{ Exposures: }} The exposure groups were patients diagnosed with a specific cancer, whereas the unexposed groups were patients without the specific cancer. !!{{ Main outcomes and measures: }} The adjusted odds ratio (aOR) and 95% CI were estimated using the Cochran-Mantel-Haenszel test for the risk of COVID-19 infection. !!{{ Results: }} Among the 73.4 million patients included in the analysis (53.6% female), 2 523 920 had at least 1 of the 13 common cancers diagnosed (all cancer diagnosed within or before the last year), and 273 140 had recent cancer (cancer diagnosed within the last year). Among 16 570 patients diagnosed with COVID-19, 1200 had a cancer diagnosis and 690 had a recent cancer diagnosis of at least 1 of the 13 common cancers. Those with recent cancer diagnosis were at significantly increased risk for COVID-19 infection (aOR, 7.14 [95% CI, 6.91-7.39]; P &lt; .001), with the strongest association for recently diagnosed leukemia (aOR, 12.16 [95% CI, 11.03-13.40]; P &lt; .001), non-Hodgkin lymphoma (aOR, 8.54 [95% CI, 7.80-9.36]; P &lt; .001), and lung cancer (aOR, 7.66 [95% CI, 7.07-8.29]; P &lt; .001) and weakest for thyroid cancer (aOR, 3.10 [95% CI, 2.47-3.87]; P &lt; .001). Among patients with recent cancer diagnosis, African Americans had a significantly higher risk for COVID-19 infection than White patients; this racial disparity was largest for breast cancer (aOR, 5.44 [95% CI, 4.69-6.31]; P &lt; .001), followed by prostate cancer (aOR, 5.10 [95% CI, 4.34-5.98]; P &lt; .001), colorectal cancer (aOR, 3.30 [95% CI, 2.55-4.26]; P &lt; .001), and lung cancer (aOR, 2.53 [95% CI, 2.10-3.06]; P &lt; .001). Patients with cancer and COVID-19 had significantly worse outcomes (hospitalization, 47.46%; death, 14.93%) than patients with COVID-19 without cancer (hospitalization, 24.26%; death, 5.26%) (P &lt; .001) and patients with cancer without COVID-19 (hospitalization, 12.39%; death, 4.03%) (P &lt; .001). !!{{ Conclusions and relevance: }} In this case-control study, patients with cancer were at significantly increased risk for COVID-19 infection and worse outcomes, which was further exacerbated among African Americans. These findings highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7729584/ 689 2374-2437 JAMA Oncology Chicago, Il : American Medical Association
22105 114788 MERS Item Term Item abstract 2540 https://doi.org/10.1136/bmjopen-2021-051711 Diabetes, obesity, hypertension and risk of severe COVID-19: a protocol for systematic review and meta-analysis Chaoyang Li|||Nazrul Islam|||Juan Pablo Gutierrez|||Ben Lacey|||Ronald L Moolenaar|||Patricia Richter 202111 Article PMC {{{ Abstract }}} !!{{ Introduction: }} Previous evidence from several countries, including China, Italy, Mexico, UK and the USA, indicates that among patients with confirmed COVID-19 who were hospitalised, diabetes, obesity and hypertension might be important risk factors for severe clinical outcomes. Several preliminary systematic reviews and meta-analyses have been conducted on one or more of these non-communicable diseases, but the findings have not been definitive, and recent evidence has become available from many more populations. Thus, we aim to conduct a systematic review and meta-analysis of observational studies to assess the relationship of diabetes, obesity and hypertension with severe clinical outcomes in patients with COVID-19. !!{{ Method and analysis: }} We will search 16 major databases (MEDLINE, Embase, Global Health, CAB Abstracts, PsycINFO, CINAHL, Academic Research Complete, Africa Wide Information, Scopus, PubMed Central, ProQuest Central, WHO Virtual Health Library, Homeland Security COVID-19 collection, SciFinder, Clinical Trials and Cochrane Library) for articles published between December 2019 and December 2020. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2016 guidelines for the design and reporting the results. We will include observational studies that assess the associations of pre-existing diabetes, obesity and hypertension in patients with COVID-19 with risk of severe clinical outcomes such as intensive care unit admission, receiving mechanical ventilation or death. Stata V.16.1 and R-Studio V.1.4.1103 statistical software will be used for statistical analysis. Meta-analysis will be used to estimate the pooled risks and to assess potential heterogeneities in risks. !!{{ Ethics and dissemination: }} The study was reviewed for human subjects concerns by the US CDC Center for Global Health and determined to not represent human subjects research because it uses data from published studies. We plan to publish results in a peer-reviewed journal and present at national and international conferences. !!{{ Prospero registration number: }} CRD42021204371. !!{{ Keywords: }} COVID-19; diabetes &amp; endocrinology; epidemiology; hypertension. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8628113/ 8 2044-6055 BMJ Open [London] : BMJ Publishing Group Ltd
11116 114788 MERS racial disparity Term racial disparity abstract 인종적 불균형 202823 https://doi.org/10.1001/jamaoncol.2020.6178 Analyses of Risk, Racial Disparity, and Outcomes Among US Patients With Cancer and COVID-19 Infection QuanQiu Wang|||Nathan A Berger|||Rong Xu 202102 pubmed {{ Importance: }} Patients with specific cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19) and its severe outcomes. At present, limited data are available on the risk, racial disparity, and outcomes for COVID-19 illness in patients with cancer. !!{{ Objectives: }} To investigate how patients with specific types of cancer are at risk for COVID-19 infection and its adverse outcomes and whether there are cancer-specific race disparities for COVID-19 infection. !!{{ Design, setting, and participants: }} This retrospective case-control analysis of patient electronic health records included 73.4 million patients from 360 hospitals and 317 000 clinicians across 50 US states to August 14, 2020. The odds of COVID-19 infections for 13 common cancer types and adverse outcomes were assessed. !!{{ Exposures: }} The exposure groups were patients diagnosed with a specific cancer, whereas the unexposed groups were patients without the specific cancer. !!{{ Main outcomes and measures: }} The adjusted odds ratio (aOR) and 95% CI were estimated using the Cochran-Mantel-Haenszel test for the risk of COVID-19 infection. !!{{ Results: }} Among the 73.4 million patients included in the analysis (53.6% female), 2 523 920 had at least 1 of the 13 common cancers diagnosed (all cancer diagnosed within or before the last year), and 273 140 had recent cancer (cancer diagnosed within the last year). Among 16 570 patients diagnosed with COVID-19, 1200 had a cancer diagnosis and 690 had a recent cancer diagnosis of at least 1 of the 13 common cancers. Those with recent cancer diagnosis were at significantly increased risk for COVID-19 infection (aOR, 7.14 [95% CI, 6.91-7.39]; P &lt; .001), with the strongest association for recently diagnosed leukemia (aOR, 12.16 [95% CI, 11.03-13.40]; P &lt; .001), non-Hodgkin lymphoma (aOR, 8.54 [95% CI, 7.80-9.36]; P &lt; .001), and lung cancer (aOR, 7.66 [95% CI, 7.07-8.29]; P &lt; .001) and weakest for thyroid cancer (aOR, 3.10 [95% CI, 2.47-3.87]; P &lt; .001). Among patients with recent cancer diagnosis, African Americans had a significantly higher risk for COVID-19 infection than White patients; this racial disparity was largest for breast cancer (aOR, 5.44 [95% CI, 4.69-6.31]; P &lt; .001), followed by prostate cancer (aOR, 5.10 [95% CI, 4.34-5.98]; P &lt; .001), colorectal cancer (aOR, 3.30 [95% CI, 2.55-4.26]; P &lt; .001), and lung cancer (aOR, 2.53 [95% CI, 2.10-3.06]; P &lt; .001). Patients with cancer and COVID-19 had significantly worse outcomes (hospitalization, 47.46%; death, 14.93%) than patients with COVID-19 without cancer (hospitalization, 24.26%; death, 5.26%) (P &lt; .001) and patients with cancer without COVID-19 (hospitalization, 12.39%; death, 4.03%) (P &lt; .001). !!{{ Conclusions and relevance: }} In this case-control study, patients with cancer were at significantly increased risk for COVID-19 infection and worse outcomes, which was further exacerbated among African Americans. These findings highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7729584/ 689 2374-2437 JAMA Oncology Chicago, Il : American Medical Association
10965 114788 MERS severe coronavirus disease Disease severe coronavirus disease title 중증 코로나바이러스 질환 202005 https://doi.org/10.1111/1471-0528.16935 Pregnancy and the risk of severe coronavirus disease 2019 infection: methodological challenges and research recommendations D A Savitz|||A M Bengtson|||E Hardy|||D B Fell 202201 PMC None https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8652522/ 1796 1470-0328 BJOG : an international journal of obstetrics and Oxford : Wiley-Blackwell.
11251 114788 MERS IgG antibody Protein IgG antibody abstract IgG 항체 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11217 114788 MERS B.1.617.2 Virus B.1.617.2 abstract 델타 변이 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11232 114788 MERS COVID-19 vaccine Drug COVID-19 vaccine title 코로나19 백신 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11216 114788 MERS B.1.1.529 Virus B.1.1.529 abstract 오미크론 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11220 114788 MERS blind Term blind title 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11224 114788 MERS booster vaccination Term booster vaccination title 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
11226 114788 MERS Brazil Institution Brazil title,abstract 브라질 595 https://doi.org/10.1016/S0140-6736(22)00094-0 Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study 202202 Clinical Trial PMC Summary Introduction The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses. Methods RHH-001 is a phase 4, participant masked, two centre, safety and immunogenicity study of Brazilian adults (18 years and older) in S?o Paulo or Salvador who had received two doses of CoronaVac 6 months previously. The third heterologous dose was of either a recombinant adenoviral vectored vaccine (Ad26.COV2-S, Janssen), an mRNA vaccine (BNT162b2, Pfizer?BioNTech), or a recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine (AZD1222, AstraZeneca), compared with a third homologous dose of CoronaVac. Participants were randomly assigned (5:6:5:5) by a RedCAP computer randomisation system stratified by site, age group (18?60 years or 61 years and over), and day of randomisation, with a block size of 42. The primary outcome was non-inferiority of anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen, using a non-inferiority margin for the geometric mean ratio (heterologous vs homologous) of 0·67. Secondary outcomes included neutralising antibody titres at day 28, local and systemic reactogenicity profiles, adverse events, and serious adverse events. This study was registered with Registro Brasileiro de Ensaios Cl?nicos, number RBR?9nn3scw. Findings Between Aug 16, and Sept 1, 2021, 1240 participants were randomly assigned to one of the four groups, of whom 1239 were vaccinated and 1205 were eligible for inclusion in the primary analysis. Antibody concentrations were low before administration of a booster dose with detectable neutralising antibodies of 20·4% (95% CI 12·8?30·1) in adults aged 18?60 years and 8·9% (4·2?16·2) in adults 61 years or older. From baseline to day 28 after the booster vaccine, all groups had a substantial rise in IgG antibody concentrations: the geometric fold-rise was 77 (95% CI 67?88) for Ad26.COV2-S, 152 (134?173) for BNT162b2, 90 (77?104) for ChAdOx1 nCoV-19, and 12 (11?14) for CoronaVac. All heterologous regimens had anti-spike IgG responses at day 28 that were superior to homologous booster responses: geometric mean ratios (heterologous vs homologous) were 6·7 (95% CI 5·8?7·7) for Ad26.COV2-S, 13·4 (11·6?15·3) for BNT162b2, and 7·0 (6·1?8·1) for ChAdOx1 nCoV-19. All heterologous boost regimens induced high concentrations of pseudovirus neutralising antibodies. At day 28, all groups except for the homologous boost in the older adults reached 100% seropositivity: geometric mean ratios (heterologous vs homologous) were 8·7 (95% CI 5·9?12·9) for Ad26.COV2-S vaccine, 21·5 (14·5?31·9) for BNT162b2, and 10·6 (7·2?15·6) for ChAdOx1 nCoV-19. Live virus neutralising antibodies were also boosted against delta (B.1.617.2) and omicron variants (B.1.1.529). There were five serious adverse events. Three of which were considered possibly related to the vaccine received: one in the BNT162b2 group and two in the Ad26.COV2-S group. All participants recovered and were discharged home. Interpretation Antibody concentrations were low at 6 months after previous immunisation with two doses of CoronaVac. However, all four vaccines administered as a third dose induced a significant increase in binding and neutralising antibodies, which could improve protection against infection. Heterologous boosting resulted in more robust immune responses than homologous boosting and might enhance protection. Funding Ministry of Health, Brazil. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8782575/ 38 0140-6736 Lancet (London, England) London : Elsevier.
14658 114788 MERS provided Action provided abstract 27180 https://doi.org/10.1186/s12909-021-03000-3 Can a virtual microbiology simulation be as effective as the traditional Wetlab for pharmacy student education? L. Baumann-Birkbeck|||S. Anoopkumar-Dukie|||S. A. Khan|||M. J. Cheesman|||M. O’Donoghue|||G. D. Grant 202111 Trial PMC Background Pharmacy practice education requires the development of proficiencies and an understanding of clinical microbiology. Learning in this area could be delivered using practical laboratory exercises, or potentially, simulation-based education. Simulation has previously successfully enhanced learning in health professional education. The current global climate due to COVID-19 has further highlighted the important role of technology-enhanced learning in delivering outcomes that meet the requisite learning objectives of a course. The aim of the present study was to compare the impact of a commercially available virtual microbiology simulation (VUMIE™) with a traditional wet laboratory (wetlab) on learner knowledge, skills and confidence in a second-year integrated pharmacotherapeutics course for Bachelor of Pharmacy students. Methods A randomised, crossover study was employed to determine whether the simulation intervention (VUMIE™) improves learning outcomes (knowledge, skills and confidence) of pharmacy students, when compared to a traditional wetlab intervention. Each student completed three 1?2?h length sessions, for both the wetlab and VUMIE™ interventions (6 sessions total). Data was collected using surveys deployed at baseline (pre-interventions), post-intervention 1 or 2 (VUMIE™ or wetlab) and endpoint (post-interventions 1 and 2). Statistical analysis was conducted using SPSS Statistics 25 and Instat™ software. Results Response rates were approximately 50% at initial survey and approximately 25% at endpoint survey. VUMIE™ produced higher post-intervention knowledge scores for the multiple-choice questions compared to the wetlab, however, the highest score was achieved at endpoint. Both interventions produced statistically significant differences for mean scores compared to baseline (pre-VUMIE™ and wetlab) across the domains of knowledge, skills and confidence. VUMIE™ produced higher post-intervention mean scores for knowledge, skills and confidence compared to post-intervention mean scores for the wetlab, however there was no statistical significance between the mean score for the two interventions, thus the VUMIE™ activity produced learning outcomes comparable to the wetlab activity. Conclusion These findings suggest VUMIE™ provides similar effects on students’ knowledge, skills, and confidence as a wetlab. The simulation’s implementation was not cost-prohibitive, provided students with a physically and psychologically safe learning environment, and the benefit of being able to repeat activities, supporting deliberate practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8596346/ 460 1472-6920 BMC Medical Education London : BioMed Central
12509 114788 MERS participants Patient participants abstract 10018 https://doi.org/10.3389/fpubh.2021.674035 Health Related Social Needs Among Chinese American Primary Care Patients During the COVID-19 Pandemic: Implications for Cancer Screening and Primary Care Jennifer Tsui|||Annie Yang|||Bianca Anuforo|||Jolene Chou|||Ruth Brogden|||Binghong Xu|||Joel C. Cantor|||Su Wang 202105 Public Health PMC Research Objective: Initiatives to address social determinants of health (SDOH) and measure health-related social needs (HRSN) within clinic settings are increasing. However, few have focused on the specific needs of Asian Americans (AA). We examine the prevalence of HRSN during a period spanning the COVID-19 pandemic to inform strategies to improve cancer screening and primary care among AA patients. Methods: We implemented a self-administered HRSN screening tool in English and Chinese, traditional (T) or simplified (S) text, within a hospital-affiliated, outpatient primary care practice predominantly serving AA in New Jersey. HRSN items included food insecurity, transportation barriers, utility needs, interpersonal violence, housing instability, immigration history, and neighborhood perceptions on cohesion and trust. We conducted medical chart reviews for a subset of participants to explore the relationship between HRSN and history of cancer screening. Results: Among 236 participants, most were Asian (74%), non-US born (79%), and privately insured (57%). One-third responded in Chinese (37%). Half reported having ≥1 HRSN. Interpersonal violence was high across all participants. Transportation needs were highest among Chinese-T participants, while food insecurity and housing instability were higher among Chinese-S participants. Lower-income patients had higher odds of having ≥2 HRSN (OR:2.53, 95% CI: 1.12, 5.98). Older age and public insurance/uninsured were significantly associated with low neighborhood perceptions. Conclusions: We observed higher than anticipated reports of HRSN among primary care patients in a suburban, hospital-affiliated practice serving AA. Low neighborhood perceptions, particularly among Chinese-S participants, highlight the importance of addressing broader SDOH among insured, suburban AA patients. These study findings inform the need to augment HRSN identification to adequately address social needs that impact health outcomes and life course experiences for Asian patients. As HRSN measuring efforts continue, and COVID-19's impact on the health of minority communities emerge, it will be critical to develop community-specific referral pathways to connect AA to resources for HRSN and continue to address more upstream social determinants of health for those who are disproportionately impacted. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8192797/ 207 2296-2565 Frontiers in Public Health Lausanne : Frontiers Editorial Office.
16448 114788 MERS antipyretics Term antipyretics abstract 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
13542 114788 MERS hospitalized Term hospitalized abstract 입원 13507 https://doi.org/10.1111/aas.14109 Longitudinal changes in inflammatory biomarkers among patients with COVID-19: A nationwide study in Iceland Thora Oskarsdottir|||Martin I Sigurdsson|||Runolfur Palsson|||Elias Eythorsson 202209 Article PMC {{{ Abstract }}} !!{{ Objectives: }} All SARS-CoV-2-positive persons in Iceland were prospectively monitored and those who required outpatient evaluation or were admitted to hospital underwent protocolized evaluation that included a standardized panel of biomarkers. The aim was to describe longitudinal changes in inflammatory biomarkers throughout the infection period of patients with COVID-19 requiring different levels of care. !!{{ Design: }} Registry-based study. !!{{ Setting: }} Nationwide study in Iceland. !!{{ Patients: }} All individuals who tested positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) from February 28 to December 31, 2020 in Iceland and had undergone blood tests between 5 days before and 21 days following onset of symptoms. !!{{ Measurements and main results: }} Data were collected from the electronic medical record system of Landspitali-The National University Hospital of Iceland. Data analyses were descriptive and the evolution of biomarkers was visualized using locally weighted scatterplot smoothing curves stratified by the worst clinical outcome experienced by the patient: outpatient evaluation only, hospitalization, and either intensive care unit (ICU) admission or death. Of 571 included patients, 310 (54.3%) only required outpatient evaluation or treatment, 202 (35.4%) were hospitalized, and 59 (10.3%) were either admitted to the ICU or died. An early and persistent separation of the mean lymphocyte count and plasma C-reactive protein (CRP) and ferritin levels was observed between the three outcome groups, which occurred prior to hospitalization for those who later were admitted to ICU or died. Lower lymphocyte count, and higher CRP and ferritin levels correlated with worse clinical outcomes. Patients who were either admitted to the ICU or died had sustained higher white blood cell and neutrophil counts, and elevated plasma levels of procalcitonin and D-dimer compared with the other groups. !!{{ Conclusions: }} Lymphocyte count and plasma CRP and ferritin levels might be suitable parameters to assess disease severity early during COVID-19 and may serve as predictors of worse outcome. !!{{ Keywords: }} COVID-19; SARS-CoV-2; ambulatory care; critical care; laboratory markers; outcome. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/9350372/ 550 0001-5172 Acta Anaesthesiologica Scandinavica Oxford, UK : Wiley-Blackwell.
14670 114788 MERS the mean Term mean abstract 27180 https://doi.org/10.1186/s12909-021-03000-3 Can a virtual microbiology simulation be as effective as the traditional Wetlab for pharmacy student education? L. Baumann-Birkbeck|||S. Anoopkumar-Dukie|||S. A. Khan|||M. J. Cheesman|||M. O’Donoghue|||G. D. Grant 202111 Trial PMC Background Pharmacy practice education requires the development of proficiencies and an understanding of clinical microbiology. Learning in this area could be delivered using practical laboratory exercises, or potentially, simulation-based education. Simulation has previously successfully enhanced learning in health professional education. The current global climate due to COVID-19 has further highlighted the important role of technology-enhanced learning in delivering outcomes that meet the requisite learning objectives of a course. The aim of the present study was to compare the impact of a commercially available virtual microbiology simulation (VUMIE™) with a traditional wet laboratory (wetlab) on learner knowledge, skills and confidence in a second-year integrated pharmacotherapeutics course for Bachelor of Pharmacy students. Methods A randomised, crossover study was employed to determine whether the simulation intervention (VUMIE™) improves learning outcomes (knowledge, skills and confidence) of pharmacy students, when compared to a traditional wetlab intervention. Each student completed three 1?2?h length sessions, for both the wetlab and VUMIE™ interventions (6 sessions total). Data was collected using surveys deployed at baseline (pre-interventions), post-intervention 1 or 2 (VUMIE™ or wetlab) and endpoint (post-interventions 1 and 2). Statistical analysis was conducted using SPSS Statistics 25 and Instat™ software. Results Response rates were approximately 50% at initial survey and approximately 25% at endpoint survey. VUMIE™ produced higher post-intervention knowledge scores for the multiple-choice questions compared to the wetlab, however, the highest score was achieved at endpoint. Both interventions produced statistically significant differences for mean scores compared to baseline (pre-VUMIE™ and wetlab) across the domains of knowledge, skills and confidence. VUMIE™ produced higher post-intervention mean scores for knowledge, skills and confidence compared to post-intervention mean scores for the wetlab, however there was no statistical significance between the mean score for the two interventions, thus the VUMIE™ activity produced learning outcomes comparable to the wetlab activity. Conclusion These findings suggest VUMIE™ provides similar effects on students’ knowledge, skills, and confidence as a wetlab. The simulation’s implementation was not cost-prohibitive, provided students with a physically and psychologically safe learning environment, and the benefit of being able to repeat activities, supporting deliberate practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8596346/ 460 1472-6920 BMC Medical Education London : BioMed Central
13548 114788 MERS intensive care Term intensive care abstract 집중치료 13507 https://doi.org/10.1111/aas.14109 Longitudinal changes in inflammatory biomarkers among patients with COVID-19: A nationwide study in Iceland Thora Oskarsdottir|||Martin I Sigurdsson|||Runolfur Palsson|||Elias Eythorsson 202209 Article PMC {{{ Abstract }}} !!{{ Objectives: }} All SARS-CoV-2-positive persons in Iceland were prospectively monitored and those who required outpatient evaluation or were admitted to hospital underwent protocolized evaluation that included a standardized panel of biomarkers. The aim was to describe longitudinal changes in inflammatory biomarkers throughout the infection period of patients with COVID-19 requiring different levels of care. !!{{ Design: }} Registry-based study. !!{{ Setting: }} Nationwide study in Iceland. !!{{ Patients: }} All individuals who tested positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) from February 28 to December 31, 2020 in Iceland and had undergone blood tests between 5 days before and 21 days following onset of symptoms. !!{{ Measurements and main results: }} Data were collected from the electronic medical record system of Landspitali-The National University Hospital of Iceland. Data analyses were descriptive and the evolution of biomarkers was visualized using locally weighted scatterplot smoothing curves stratified by the worst clinical outcome experienced by the patient: outpatient evaluation only, hospitalization, and either intensive care unit (ICU) admission or death. Of 571 included patients, 310 (54.3%) only required outpatient evaluation or treatment, 202 (35.4%) were hospitalized, and 59 (10.3%) were either admitted to the ICU or died. An early and persistent separation of the mean lymphocyte count and plasma C-reactive protein (CRP) and ferritin levels was observed between the three outcome groups, which occurred prior to hospitalization for those who later were admitted to ICU or died. Lower lymphocyte count, and higher CRP and ferritin levels correlated with worse clinical outcomes. Patients who were either admitted to the ICU or died had sustained higher white blood cell and neutrophil counts, and elevated plasma levels of procalcitonin and D-dimer compared with the other groups. !!{{ Conclusions: }} Lymphocyte count and plasma CRP and ferritin levels might be suitable parameters to assess disease severity early during COVID-19 and may serve as predictors of worse outcome. !!{{ Keywords: }} COVID-19; SARS-CoV-2; ambulatory care; critical care; laboratory markers; outcome. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/9350372/ 550 0001-5172 Acta Anaesthesiologica Scandinavica Oxford, UK : Wiley-Blackwell.
13549 114788 MERS laboratory Institution laboratory abstract 실험실 13507 https://doi.org/10.1111/aas.14109 Longitudinal changes in inflammatory biomarkers among patients with COVID-19: A nationwide study in Iceland Thora Oskarsdottir|||Martin I Sigurdsson|||Runolfur Palsson|||Elias Eythorsson 202209 Article PMC {{{ Abstract }}} !!{{ Objectives: }} All SARS-CoV-2-positive persons in Iceland were prospectively monitored and those who required outpatient evaluation or were admitted to hospital underwent protocolized evaluation that included a standardized panel of biomarkers. The aim was to describe longitudinal changes in inflammatory biomarkers throughout the infection period of patients with COVID-19 requiring different levels of care. !!{{ Design: }} Registry-based study. !!{{ Setting: }} Nationwide study in Iceland. !!{{ Patients: }} All individuals who tested positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) from February 28 to December 31, 2020 in Iceland and had undergone blood tests between 5 days before and 21 days following onset of symptoms. !!{{ Measurements and main results: }} Data were collected from the electronic medical record system of Landspitali-The National University Hospital of Iceland. Data analyses were descriptive and the evolution of biomarkers was visualized using locally weighted scatterplot smoothing curves stratified by the worst clinical outcome experienced by the patient: outpatient evaluation only, hospitalization, and either intensive care unit (ICU) admission or death. Of 571 included patients, 310 (54.3%) only required outpatient evaluation or treatment, 202 (35.4%) were hospitalized, and 59 (10.3%) were either admitted to the ICU or died. An early and persistent separation of the mean lymphocyte count and plasma C-reactive protein (CRP) and ferritin levels was observed between the three outcome groups, which occurred prior to hospitalization for those who later were admitted to ICU or died. Lower lymphocyte count, and higher CRP and ferritin levels correlated with worse clinical outcomes. Patients who were either admitted to the ICU or died had sustained higher white blood cell and neutrophil counts, and elevated plasma levels of procalcitonin and D-dimer compared with the other groups. !!{{ Conclusions: }} Lymphocyte count and plasma CRP and ferritin levels might be suitable parameters to assess disease severity early during COVID-19 and may serve as predictors of worse outcome. !!{{ Keywords: }} COVID-19; SARS-CoV-2; ambulatory care; critical care; laboratory markers; outcome. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/9350372/ 550 0001-5172 Acta Anaesthesiologica Scandinavica Oxford, UK : Wiley-Blackwell.
13556 114788 MERS neutrophil counts Term neutrophil counts abstract 호중구 수 13507 https://doi.org/10.1111/aas.14109 Longitudinal changes in inflammatory biomarkers among patients with COVID-19: A nationwide study in Iceland Thora Oskarsdottir|||Martin I Sigurdsson|||Runolfur Palsson|||Elias Eythorsson 202209 Article PMC {{{ Abstract }}} !!{{ Objectives: }} All SARS-CoV-2-positive persons in Iceland were prospectively monitored and those who required outpatient evaluation or were admitted to hospital underwent protocolized evaluation that included a standardized panel of biomarkers. The aim was to describe longitudinal changes in inflammatory biomarkers throughout the infection period of patients with COVID-19 requiring different levels of care. !!{{ Design: }} Registry-based study. !!{{ Setting: }} Nationwide study in Iceland. !!{{ Patients: }} All individuals who tested positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) from February 28 to December 31, 2020 in Iceland and had undergone blood tests between 5 days before and 21 days following onset of symptoms. !!{{ Measurements and main results: }} Data were collected from the electronic medical record system of Landspitali-The National University Hospital of Iceland. Data analyses were descriptive and the evolution of biomarkers was visualized using locally weighted scatterplot smoothing curves stratified by the worst clinical outcome experienced by the patient: outpatient evaluation only, hospitalization, and either intensive care unit (ICU) admission or death. Of 571 included patients, 310 (54.3%) only required outpatient evaluation or treatment, 202 (35.4%) were hospitalized, and 59 (10.3%) were either admitted to the ICU or died. An early and persistent separation of the mean lymphocyte count and plasma C-reactive protein (CRP) and ferritin levels was observed between the three outcome groups, which occurred prior to hospitalization for those who later were admitted to ICU or died. Lower lymphocyte count, and higher CRP and ferritin levels correlated with worse clinical outcomes. Patients who were either admitted to the ICU or died had sustained higher white blood cell and neutrophil counts, and elevated plasma levels of procalcitonin and D-dimer compared with the other groups. !!{{ Conclusions: }} Lymphocyte count and plasma CRP and ferritin levels might be suitable parameters to assess disease severity early during COVID-19 and may serve as predictors of worse outcome. !!{{ Keywords: }} COVID-19; SARS-CoV-2; ambulatory care; critical care; laboratory markers; outcome. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/9350372/ 550 0001-5172 Acta Anaesthesiologica Scandinavica Oxford, UK : Wiley-Blackwell.
14737 114788 MERS screening test Test screening test abstract 선별검사 27699 https://doi.org/10.1038/s41598-021-90100-1 Proper use of noncontact infrared thermometry for temperature screening during COVID-19 Amber S. Hussain|||Heather S. Hussain|||Nathan Betcher|||Robert Behm|||Burt Cagir 202106 Observational Study PMC Among the myriad of challenges healthcare institutions face in dealing with coronavirus disease 2019 (COVID?19), screening for the detection of febrile persons entering facilities remains problematic, particularly when paired with CDC and WHO spatial distancing guidance.?Aggressive source control measures during the outbreak of COVID-19 has led to re-purposed use of noncontact infrared thermometry (NCIT) for temperature screening. This study was commissioned to establish the efficacy of this technology for temperature screening by healthcare facilities. We conducted a prospective, observational, single-center study in a level II trauma center at the onset of the COVID-19 outbreak to assess (i) method agreement between NCIT and temporal artery reference temperature, (ii) diagnostic accuracy of NCIT in detecting referent temperature \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\ge 100.0\,^{\circ }{\mathrm{F}}$$\end{document} ≥ 100.0 ? F and ensuing test sensitivity and specificity and (iii) technical limitations of this technology. Of 51 healthy, non-febrile, healthcare workers?surveyed,?the mean temporal artery temperature was \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$98.4\,^{\circ }{\mathrm{F}}$$\end{document} 98.4 ? F ( \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$95\%$$\end{document} 95 % confidence interval (CI)?= \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$[98.2,98.6]\,^{\circ }{\mathrm{F}}$$\end{document} [ 98.2 , 98.6 ] ? F ). Mean NCIT temperatures measured from \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${1}\,{\mathrm{ft}}$$\end{document} 1 ft , \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${3}\,{\mathrm{ft}}$$\end{document} 3 ft , and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${6}\,{\mathrm{ft}}$$\end{document} 6 ft distances were \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$92.2\,^{\circ }{\mathrm{F}}$$\end{document} 92.2 ? F \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$(95\%\ {\text {CI}}=[91.8\ 92.67]\,^{\circ }{\mathrm{F}})$$\end{document} ( 95 % CI = [ 91.8 92.67 ] ? F ) , \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$91.3\,^{\circ }{\mathrm{F}}$$\end{document} 91.3 ? F \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$(95\%\ {\text {CI}}=[90.8\ 91.8]\,^{\circ }{\mathrm{F}})$$\end{document} ( 95 % CI = [ 90.8 91.8 ] ? F ) , and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$89.6\,^{\circ }{\mathrm{F}}$$\end{document} 89.6 ? F \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$(95\%\ {\text {CI}}=[89.2 \ 90.1]\,^{\circ }{\mathrm{F}})$$\end{document} ( 95 % CI = [ 89.2 90.1 ] ? F ) , respectively. From statistical analysis,?the only method in sufficient agreement with the reference standard was NCIT at \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${1}\,{\mathrm{ft}}$$\end{document} 1 ft . This demonstrated that the device offset (mean temperature difference) between these methods was \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$-6.15\,^{\circ }{\mathrm{F}}$$\end{document} - 6.15 ? F ( \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$95\%\ {\text {CI}}=[-6.56,-5.74]\,^{\circ }{\mathrm{F}}$$\end{document} 95 % CI = [ - 6.56 , - 5.74 ] ? F ) with 95% of measurement differences within \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$-8.99\,^{\circ }{\mathrm{F}}$$\end{document} - 8.99 ? F ( \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$95\%\ {\text {CI}}=[-9.69,-8.29]\,^{\circ }{\mathrm{F}}$$\end{document} 95 % CI = [ - 9.69 , - 8.29 ] ? F ) and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$-3.31\,^{\circ }{\mathrm{F}}$$\end{document} - 3.31 ? F ( \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$95\%\ {\text {CI}}= [-4.00,-2.61]\,^{\circ }{\mathrm{F}}$$\end{document} 95 % CI = [ - 4.00 , - 2.61 ] ? F ). By setting the NCIT screening threshold to \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$93.5\,^{\circ }{\mathrm{F}}$$\end{document} 93.5 ? F at \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${1}\,{\mathrm{ft}}$$\end{document} 1 ft , we achieve diagnostic accuracy with \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$70.9\%$$\end{document} 70.9 % test?sensitivity and specificity for temperature detection \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\ge 100.0\,^{\circ }{\mathrm{F}}$$\end{document} ≥ 100.0 ? F by reference standard. In comparison,?reducing?this screening criterion to the lower limit of the device-specific offset, such as \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$91.1\,^{\circ }{\mathrm{F}}$$\end{document} 91.1 ? F , produces a highly sensitive screening test at \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$98.2\%$$\end{document} 98.2 % , which may be favorable in high-risk pandemic disease. For future consideration,?an infrared device with a higher?distance-to-spot size ratio approaching 50:1?would theoretically produce similar results at \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${6}\,{\mathrm{ft}}$$\end{document} 6 ft , in?accordance with?CDC and WHO spatial distancing guidelines. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8178358/ 53 2045-2322 Scientific Reports London : Nature Publishing Group
16451 114788 MERS arms Organ arms abstract 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
15508 114788 MERS Mortality Term mortality author 치사성 42861 https://doi.org/10.36660/abc.20210041 Parada Cardiorrespirat?ria Extra-Hospitalar durante a Pandemia da Doen?a por Coronav?rus 2019 (COVID-19) no Brasil: A Mortalidade Oculta Claudio Tinoco Mesquita|||Claudio Tinoco Mesquita 202102 Minieditorial PMC Resumo O mundo mudou em apenas alguns meses ap?s o surgimento da doen?a do novo coronav?rus 2019 (COVID-19), causada por um betacoronav?rus denominado s?ndrome respirat?ria aguda grave por coronav?rus 2 (SARS-CoV-2). A COVID-19 foi declarada uma pandemia pela Organiza??o Mundial da Sa?de (OMS) em 11 de mar?o de 2020. O Brasil apresenta atualmente o segundo maior ?ndice de mortalidade por COVID-19 do mundo, perdendo apenas para os EUA. A pandemia da COVID-19 est? se espalhando rapidamente pelo mundo, com mais de 181 pa?ses afetados. O presente editorial se refere ao artigo publicado nos Arquivos Brasileiros de Cardiologia: “Aumento de ?bitos domiciliares devido a parada cardiorrespirat?ria em tempos de pandemia de COVID-19” 1 Seus principais resultados mostram um aumento gradual na taxa de paradas cardiorrespirat?rias extra-hospitalares durante a pandemia da doen?a por coronav?rus 2019 (COVID-19) na cidade de Belo Horizonte, Minas Gerais, Brasil. Seus dados demonstram um aumento proporcional de 33% dos ?bitos domiciliares em mar?o de 2020 em rela??o aos per?odos anteriores. O estudo ? o primeiro artigo brasileiro a demonstrar a mesma tend?ncia observada em outros pa?ses. Abstract The world changed in just a few months after the emergence of the novel coronavirus disease 2019 (COVID-19), caused by a beta coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Brazil currently has the world’s second-highest COVID-19 death toll, second only to the USA. The COVID-19 pandemic is spreading fast in the world with more than 181 countries affected. This editorial refers to the article published in Arquivos Brasileiros de Cardiologia: “Increase in home deaths due to cardiorespiratory arrest in times of COVID-19 pandemic.” 1 Their main results show a gradual increase in the rate of out-of-hospital cardiac arrest during the Coronavirus disease 2019 (COVID-19) pandemic in the city of Belo Horizonte, Minas Gerais, Brazil. Their data demonstrate a proportional increase of 33% of home deaths in March 2020 compared to previous periods. Their study is the first Brazilian paper to demonstrate the same trend observed in other countries. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7909974/ 557 0066-782X Arquivos Brasileiros de Cardiologia Sao Paulo : Sociedad Brasileira De Cardiologia.
14634 114788 MERS effective Term effective title 효과적인 27180 https://doi.org/10.1186/s12909-021-03000-3 Can a virtual microbiology simulation be as effective as the traditional Wetlab for pharmacy student education? L. Baumann-Birkbeck|||S. Anoopkumar-Dukie|||S. A. Khan|||M. J. Cheesman|||M. O’Donoghue|||G. D. Grant 202111 Trial PMC Background Pharmacy practice education requires the development of proficiencies and an understanding of clinical microbiology. Learning in this area could be delivered using practical laboratory exercises, or potentially, simulation-based education. Simulation has previously successfully enhanced learning in health professional education. The current global climate due to COVID-19 has further highlighted the important role of technology-enhanced learning in delivering outcomes that meet the requisite learning objectives of a course. The aim of the present study was to compare the impact of a commercially available virtual microbiology simulation (VUMIE™) with a traditional wet laboratory (wetlab) on learner knowledge, skills and confidence in a second-year integrated pharmacotherapeutics course for Bachelor of Pharmacy students. Methods A randomised, crossover study was employed to determine whether the simulation intervention (VUMIE™) improves learning outcomes (knowledge, skills and confidence) of pharmacy students, when compared to a traditional wetlab intervention. Each student completed three 1?2?h length sessions, for both the wetlab and VUMIE™ interventions (6 sessions total). Data was collected using surveys deployed at baseline (pre-interventions), post-intervention 1 or 2 (VUMIE™ or wetlab) and endpoint (post-interventions 1 and 2). Statistical analysis was conducted using SPSS Statistics 25 and Instat™ software. Results Response rates were approximately 50% at initial survey and approximately 25% at endpoint survey. VUMIE™ produced higher post-intervention knowledge scores for the multiple-choice questions compared to the wetlab, however, the highest score was achieved at endpoint. Both interventions produced statistically significant differences for mean scores compared to baseline (pre-VUMIE™ and wetlab) across the domains of knowledge, skills and confidence. VUMIE™ produced higher post-intervention mean scores for knowledge, skills and confidence compared to post-intervention mean scores for the wetlab, however there was no statistical significance between the mean score for the two interventions, thus the VUMIE™ activity produced learning outcomes comparable to the wetlab activity. Conclusion These findings suggest VUMIE™ provides similar effects on students’ knowledge, skills, and confidence as a wetlab. The simulation’s implementation was not cost-prohibitive, provided students with a physically and psychologically safe learning environment, and the benefit of being able to repeat activities, supporting deliberate practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8596346/ 460 1472-6920 BMC Medical Education London : BioMed Central
14636 114788 MERS health Term health abstract 건강 27180 https://doi.org/10.1186/s12909-021-03000-3 Can a virtual microbiology simulation be as effective as the traditional Wetlab for pharmacy student education? L. Baumann-Birkbeck|||S. Anoopkumar-Dukie|||S. A. Khan|||M. J. Cheesman|||M. O’Donoghue|||G. D. Grant 202111 Trial PMC Background Pharmacy practice education requires the development of proficiencies and an understanding of clinical microbiology. Learning in this area could be delivered using practical laboratory exercises, or potentially, simulation-based education. Simulation has previously successfully enhanced learning in health professional education. The current global climate due to COVID-19 has further highlighted the important role of technology-enhanced learning in delivering outcomes that meet the requisite learning objectives of a course. The aim of the present study was to compare the impact of a commercially available virtual microbiology simulation (VUMIE™) with a traditional wet laboratory (wetlab) on learner knowledge, skills and confidence in a second-year integrated pharmacotherapeutics course for Bachelor of Pharmacy students. Methods A randomised, crossover study was employed to determine whether the simulation intervention (VUMIE™) improves learning outcomes (knowledge, skills and confidence) of pharmacy students, when compared to a traditional wetlab intervention. Each student completed three 1?2?h length sessions, for both the wetlab and VUMIE™ interventions (6 sessions total). Data was collected using surveys deployed at baseline (pre-interventions), post-intervention 1 or 2 (VUMIE™ or wetlab) and endpoint (post-interventions 1 and 2). Statistical analysis was conducted using SPSS Statistics 25 and Instat™ software. Results Response rates were approximately 50% at initial survey and approximately 25% at endpoint survey. VUMIE™ produced higher post-intervention knowledge scores for the multiple-choice questions compared to the wetlab, however, the highest score was achieved at endpoint. Both interventions produced statistically significant differences for mean scores compared to baseline (pre-VUMIE™ and wetlab) across the domains of knowledge, skills and confidence. VUMIE™ produced higher post-intervention mean scores for knowledge, skills and confidence compared to post-intervention mean scores for the wetlab, however there was no statistical significance between the mean score for the two interventions, thus the VUMIE™ activity produced learning outcomes comparable to the wetlab activity. Conclusion These findings suggest VUMIE™ provides similar effects on students’ knowledge, skills, and confidence as a wetlab. The simulation’s implementation was not cost-prohibitive, provided students with a physically and psychologically safe learning environment, and the benefit of being able to repeat activities, supporting deliberate practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8596346/ 460 1472-6920 BMC Medical Education London : BioMed Central
16489 114788 MERS Control Action control abstract 통제 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
14924 114788 MERS the SARS-CoV-2 Virus SARS-CoV-2 title 제2형 중증급성호흡기증후군 28076 https://doi.org/10.1038/s41392-021-00468-9 Structural basis for the inhibition of the SARS-CoV-2 main protease by the anti-HCV drug narlaprevir Yu Bai|||Fei Ye|||Yong Feng|||Hanyi Liao|||Hao Song|||Jianxun Qi|||George Fu Gao|||Wenjie Tan|||Lifeng Fu|||Yi Shi 202102 Letter PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7860160/ 58 2095-9907 Signal Transduction and Targeted Therapy [London] : Nature Publishing Group
16459 114788 MERS block randomization Term block randomization abstract 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
16460 114788 MERS blood Term blood abstract 혈액 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
16485 114788 MERS conditions Term conditions abstract 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
16504 114788 MERS decrease Action decrease abstract 질병 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
15502 114788 MERS Fatores de Risco Term fatores de risco author 42861 https://doi.org/10.36660/abc.20210041 Parada Cardiorrespirat?ria Extra-Hospitalar durante a Pandemia da Doen?a por Coronav?rus 2019 (COVID-19) no Brasil: A Mortalidade Oculta Claudio Tinoco Mesquita|||Claudio Tinoco Mesquita 202102 Minieditorial PMC Resumo O mundo mudou em apenas alguns meses ap?s o surgimento da doen?a do novo coronav?rus 2019 (COVID-19), causada por um betacoronav?rus denominado s?ndrome respirat?ria aguda grave por coronav?rus 2 (SARS-CoV-2). A COVID-19 foi declarada uma pandemia pela Organiza??o Mundial da Sa?de (OMS) em 11 de mar?o de 2020. O Brasil apresenta atualmente o segundo maior ?ndice de mortalidade por COVID-19 do mundo, perdendo apenas para os EUA. A pandemia da COVID-19 est? se espalhando rapidamente pelo mundo, com mais de 181 pa?ses afetados. O presente editorial se refere ao artigo publicado nos Arquivos Brasileiros de Cardiologia: “Aumento de ?bitos domiciliares devido a parada cardiorrespirat?ria em tempos de pandemia de COVID-19” 1 Seus principais resultados mostram um aumento gradual na taxa de paradas cardiorrespirat?rias extra-hospitalares durante a pandemia da doen?a por coronav?rus 2019 (COVID-19) na cidade de Belo Horizonte, Minas Gerais, Brasil. Seus dados demonstram um aumento proporcional de 33% dos ?bitos domiciliares em mar?o de 2020 em rela??o aos per?odos anteriores. O estudo ? o primeiro artigo brasileiro a demonstrar a mesma tend?ncia observada em outros pa?ses. Abstract The world changed in just a few months after the emergence of the novel coronavirus disease 2019 (COVID-19), caused by a beta coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Brazil currently has the world’s second-highest COVID-19 death toll, second only to the USA. The COVID-19 pandemic is spreading fast in the world with more than 181 countries affected. This editorial refers to the article published in Arquivos Brasileiros de Cardiologia: “Increase in home deaths due to cardiorespiratory arrest in times of COVID-19 pandemic.” 1 Their main results show a gradual increase in the rate of out-of-hospital cardiac arrest during the Coronavirus disease 2019 (COVID-19) pandemic in the city of Belo Horizonte, Minas Gerais, Brazil. Their data demonstrate a proportional increase of 33% of home deaths in March 2020 compared to previous periods. Their study is the first Brazilian paper to demonstrate the same trend observed in other countries. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7909974/ 557 0066-782X Arquivos Brasileiros de Cardiologia Sao Paulo : Sociedad Brasileira De Cardiologia.
15488 114788 MERS Brazil Institution Brazil abstract 브라질 42861 https://doi.org/10.36660/abc.20210041 Parada Cardiorrespirat?ria Extra-Hospitalar durante a Pandemia da Doen?a por Coronav?rus 2019 (COVID-19) no Brasil: A Mortalidade Oculta Claudio Tinoco Mesquita|||Claudio Tinoco Mesquita 202102 Minieditorial PMC Resumo O mundo mudou em apenas alguns meses ap?s o surgimento da doen?a do novo coronav?rus 2019 (COVID-19), causada por um betacoronav?rus denominado s?ndrome respirat?ria aguda grave por coronav?rus 2 (SARS-CoV-2). A COVID-19 foi declarada uma pandemia pela Organiza??o Mundial da Sa?de (OMS) em 11 de mar?o de 2020. O Brasil apresenta atualmente o segundo maior ?ndice de mortalidade por COVID-19 do mundo, perdendo apenas para os EUA. A pandemia da COVID-19 est? se espalhando rapidamente pelo mundo, com mais de 181 pa?ses afetados. O presente editorial se refere ao artigo publicado nos Arquivos Brasileiros de Cardiologia: “Aumento de ?bitos domiciliares devido a parada cardiorrespirat?ria em tempos de pandemia de COVID-19” 1 Seus principais resultados mostram um aumento gradual na taxa de paradas cardiorrespirat?rias extra-hospitalares durante a pandemia da doen?a por coronav?rus 2019 (COVID-19) na cidade de Belo Horizonte, Minas Gerais, Brasil. Seus dados demonstram um aumento proporcional de 33% dos ?bitos domiciliares em mar?o de 2020 em rela??o aos per?odos anteriores. O estudo ? o primeiro artigo brasileiro a demonstrar a mesma tend?ncia observada em outros pa?ses. Abstract The world changed in just a few months after the emergence of the novel coronavirus disease 2019 (COVID-19), caused by a beta coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Brazil currently has the world’s second-highest COVID-19 death toll, second only to the USA. The COVID-19 pandemic is spreading fast in the world with more than 181 countries affected. This editorial refers to the article published in Arquivos Brasileiros de Cardiologia: “Increase in home deaths due to cardiorespiratory arrest in times of COVID-19 pandemic.” 1 Their main results show a gradual increase in the rate of out-of-hospital cardiac arrest during the Coronavirus disease 2019 (COVID-19) pandemic in the city of Belo Horizonte, Minas Gerais, Brazil. Their data demonstrate a proportional increase of 33% of home deaths in March 2020 compared to previous periods. Their study is the first Brazilian paper to demonstrate the same trend observed in other countries. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7909974/ 557 0066-782X Arquivos Brasileiros de Cardiologia Sao Paulo : Sociedad Brasileira De Cardiologia.
16653 114788 MERS seizure Term seizure abstract 압수 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
16561 114788 MERS International Conference Term International Conference abstract 50690 https://doi.org/10.1186/s13063-020-04819-9 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi|||Joel V. Chua|||Rohit Talwani|||Søren M. Bentzen|||John Baddley 202010 Letter PMC Objectives Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19. Hypothesis: Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo. This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU). Trial design This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19. Participants will be followed for up to 60 days from the start of study drug administration. This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Participants Inclusion Criteria : Patients may be included in the study only if they meet all of the following criteria: 1) Ability to understand and willingness to sign a written informed consent document. Informed consent must be obtained prior to participation in the study. For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Exclusion Criteria : Patients meeting any of the following criteria are not eligible for the study: 1) Patients receiving any other investigational agents in a clinical trial. Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as: 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as: 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator’s judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study. Both men and women of all races and ethnic groups are eligible for this trial. University of Maryland Medical Center, Baltimore, MD is the initiating site. The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic. Intervention and comparator Imatinib : All doses of imatinib should be administered with a meal and a large glass of water. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions. The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs. Placebo : The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center. The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Concomitant Medications/supportive care : In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary. For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information. Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes. The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment. Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs. Main outcomes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen ? no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. The secondary endpoints include: All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events. The exploratory endpoints include: Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days. Randomization Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days. Both groups will receive the BCC. The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator. In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements: 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO 2 ≤92% on ambient air or PaO 2 /FiO 2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy. Blinding (masking) The participants, caregivers, and the statistician are blinded to group assignment. The only people who are not blinded are Site Pharmacists. Blinding will be performed via a specific randomization process. Centralized, concealed randomization will be executed by the Primary Site’s Pharmacist. Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo. Imatinib 400 mg capsules and placebo capsules will be identical form and color. For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension. Numbers to be randomized (sample size) The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to: Arm A) Imatinib or Arm B) Placebo. Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician. Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20. The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis. The proportion in Arm B (placebo control arm) is 0.30. The test statistic used is the two-sided Fisher's Exact Test. The significance level of the test is targeted at 0.05. The significance level actually achieved by this design is α=0.0385. The power of the test is calculated using binomial enumeration of all possible outcomes. The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo. The sample size is not inflated for dropouts. All patients will be evaluable irrespective of the clinical course of their disease. Trial Status Current protocol version is 1.2 from May 8, 2020. The recruitment started on June 15, 2020 and is ongoing. We originally anticipated that the trial would finish recruitment by mid 2021. We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results. We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies. For this reason, we are actively considering opening the protocol in other sites. After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites. Trial registration ClinicalTrials.gov Identifier: NCT04394416 . First Posted: May 19, 2020; Last Update Posted: June 4, 2020. FDA has issued the “Study May Proceed” Letter for this clinical trial under the Investigational New Drug (IND) number 149239. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Supplementary information Supplementary information accompanies this paper at 10.1186/s13063-020-04819-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7594416/ 54 1745-6215 Trials [London] : BioMed Central
17022 114788 MERS outcomes Term outcomes abstract 결과 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17003 114788 MERS demographic characteristics Term demographic characteristics abstract 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17004 114788 MERS diagnosed with COVID-19 Term diagnosed with COVID-19 abstract 코로나 진단을 받은 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17005 114788 MERS duration of follow-up Term duration of follow-up abstract 추적조사 기간 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17016 114788 MERS Measure Term measure abstract 척도 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17017 114788 MERS medication Term medication abstract 약물 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
16996 114788 MERS comorbidities Term comorbidities abstract 중복이환 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
16999 114788 MERS COVID-19 Disease COVID-19 title 코로나-19 53518 https://doi.org/10.1001/jamanetworkopen.2021.33090 Mortality Risk Among Patients With COVID-19 Prescribed Selective Serotonin Reuptake Inhibitor Antidepressants Tomiko Oskotsky|||Ivana Mari?|||Alice Tang|||Boris Oskotsky|||Ronald J. Wong|||Nima Aghaeepour|||Marina Sirota|||David K. Stevenson 202111 Research PMC Key Points Question Are selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine hydrochloride, associated with a lower mortality risk among patients with COVID-19? Findings In this multicenter cohort study analyzing electronic health records of 83 584 patients diagnosed with COVID-19, including 3401 patients who were prescribed SSRIs, a reduced relative risk of mortality was found to be associated with the use of SSRIs?specifically fluoxetine?compared with patients who were not prescribed SSRIs. Meaning These findings suggest that SSRI use may reduce mortality among patients with COVID-19, although they may be subject to unaccounted confounding variables; further investigation via large, randomized clinical trials is needed. This cohort study investigates whether use of selective serotonin reuptake inhibitors is associated with a reduction in the relative risk of mortality for patients with COVID-19. Importance Antidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)?specifically fluoxetine hydrochloride and fluvoxamine maleate?with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size. Objective To investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs). Design, Setting, and Participants This retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83?584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US. Exposures Selective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine). Main Outcomes and Measures Death. Results A total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P =?.03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P =?.03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P =?.04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P =?.06). Conclusions and Relevance These results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8593759/ 71 2574-3805 JAMA Network Open Chicago, IL : American Medical Association
17881 114788 MERS maintain Action maintain abstract 60931 https://doi.org/10.1111/jocs.14975 Adult cardiac surgery in Trinidad and Tobago during the COVID?19 pandemic: Lessons from a developing country Richard A. E. Ramsingh|||Jean?Luc Duval|||Natasha C. Rahaman|||Risshi D. Rampersad|||Gianni D. Angelini|||Giovanni Teodori 202008 Original Article PMC Abstract Background and Aim The coronavirus disease 2019 (COVID?19) pandemic has seen the cancellation of elective cardiac surgeries worldwide. Here we report the experience of a cardiac surgery unit in a developing country in response to the COVID?19 crisis. Methods From 6th April to 12th June 2020, 58 patients underwent urgent or emergency cardiac surgery. Data was reviewed from a prospectively entered unit?maintained cardiac surgery database. To ensure safe delivery of care to patients, a series of strict measures were implemented which included: a parallel healthcare system maintaining a COVID?19 cold site, social isolation of patients for one to 2 weeks before surgery, polymerase chain reaction testing for COVID?19, 72?hours before surgery, discrete staff assigned only to cardiac surgical cases socially isolated for 2 weeks as necessary. Results The mean age at surgery was 59.7?±?11 years and 41 (70.7%) were male. Fifty?two patients were hypertensive (90%), and 32 were diabetic (55.2%). There were three emergency type A aortic dissections. Forty?seven patients underwent coronary artery bypass graft surgery with all but three performed off?pump. Fourteen cases required blood product transfusion. One patient had postoperative pneumonia associated with chronic obstructive pulmonary disease. The median length of stay was 5.7?±?1.8 days. All patients were discharged home after rehabilitation. There were no cases of COVID?19 infection among healthcare workers during the study period. Conclusion These strategies allowed us to maintain a service for urgent and emergency procedures and may prove useful for larger countries when there is decrease in COVID?19 cases and planning for the restart of elective cardiac surgery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7461539/ 1330 0886-0440 Journal of cardiac surgery Hoboken, NJ : Wiley-Blackwell.
17882 114788 MERS male Term male abstract 남성 60931 https://doi.org/10.1111/jocs.14975 Adult cardiac surgery in Trinidad and Tobago during the COVID?19 pandemic: Lessons from a developing country Richard A. E. Ramsingh|||Jean?Luc Duval|||Natasha C. Rahaman|||Risshi D. Rampersad|||Gianni D. Angelini|||Giovanni Teodori 202008 Original Article PMC Abstract Background and Aim The coronavirus disease 2019 (COVID?19) pandemic has seen the cancellation of elective cardiac surgeries worldwide. Here we report the experience of a cardiac surgery unit in a developing country in response to the COVID?19 crisis. Methods From 6th April to 12th June 2020, 58 patients underwent urgent or emergency cardiac surgery. Data was reviewed from a prospectively entered unit?maintained cardiac surgery database. To ensure safe delivery of care to patients, a series of strict measures were implemented which included: a parallel healthcare system maintaining a COVID?19 cold site, social isolation of patients for one to 2 weeks before surgery, polymerase chain reaction testing for COVID?19, 72?hours before surgery, discrete staff assigned only to cardiac surgical cases socially isolated for 2 weeks as necessary. Results The mean age at surgery was 59.7?±?11 years and 41 (70.7%) were male. Fifty?two patients were hypertensive (90%), and 32 were diabetic (55.2%). There were three emergency type A aortic dissections. Forty?seven patients underwent coronary artery bypass graft surgery with all but three performed off?pump. Fourteen cases required blood product transfusion. One patient had postoperative pneumonia associated with chronic obstructive pulmonary disease. The median length of stay was 5.7?±?1.8 days. All patients were discharged home after rehabilitation. There were no cases of COVID?19 infection among healthcare workers during the study period. Conclusion These strategies allowed us to maintain a service for urgent and emergency procedures and may prove useful for larger countries when there is decrease in COVID?19 cases and planning for the restart of elective cardiac surgery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7461539/ 1330 0886-0440 Journal of cardiac surgery Hoboken, NJ : Wiley-Blackwell.
17893 114788 MERS pulmonary disease Disease pulmonary disease abstract 폐질환 60931 https://doi.org/10.1111/jocs.14975 Adult cardiac surgery in Trinidad and Tobago during the COVID?19 pandemic: Lessons from a developing country Richard A. E. Ramsingh|||Jean?Luc Duval|||Natasha C. Rahaman|||Risshi D. Rampersad|||Gianni D. Angelini|||Giovanni Teodori 202008 Original Article PMC Abstract Background and Aim The coronavirus disease 2019 (COVID?19) pandemic has seen the cancellation of elective cardiac surgeries worldwide. Here we report the experience of a cardiac surgery unit in a developing country in response to the COVID?19 crisis. Methods From 6th April to 12th June 2020, 58 patients underwent urgent or emergency cardiac surgery. Data was reviewed from a prospectively entered unit?maintained cardiac surgery database. To ensure safe delivery of care to patients, a series of strict measures were implemented which included: a parallel healthcare system maintaining a COVID?19 cold site, social isolation of patients for one to 2 weeks before surgery, polymerase chain reaction testing for COVID?19, 72?hours before surgery, discrete staff assigned only to cardiac surgical cases socially isolated for 2 weeks as necessary. Results The mean age at surgery was 59.7?±?11 years and 41 (70.7%) were male. Fifty?two patients were hypertensive (90%), and 32 were diabetic (55.2%). There were three emergency type A aortic dissections. Forty?seven patients underwent coronary artery bypass graft surgery with all but three performed off?pump. Fourteen cases required blood product transfusion. One patient had postoperative pneumonia associated with chronic obstructive pulmonary disease. The median length of stay was 5.7?±?1.8 days. All patients were discharged home after rehabilitation. There were no cases of COVID?19 infection among healthcare workers during the study period. Conclusion These strategies allowed us to maintain a service for urgent and emergency procedures and may prove useful for larger countries when there is decrease in COVID?19 cases and planning for the restart of elective cardiac surgery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7461539/ 1330 0886-0440 Journal of cardiac surgery Hoboken, NJ : Wiley-Blackwell.
17890 114788 MERS pneumonia Disease pneumonia abstract 폐렴 60931 https://doi.org/10.1111/jocs.14975 Adult cardiac surgery in Trinidad and Tobago during the COVID?19 pandemic: Lessons from a developing country Richard A. E. Ramsingh|||Jean?Luc Duval|||Natasha C. Rahaman|||Risshi D. Rampersad|||Gianni D. Angelini|||Giovanni Teodori 202008 Original Article PMC Abstract Background and Aim The coronavirus disease 2019 (COVID?19) pandemic has seen the cancellation of elective cardiac surgeries worldwide. Here we report the experience of a cardiac surgery unit in a developing country in response to the COVID?19 crisis. Methods From 6th April to 12th June 2020, 58 patients underwent urgent or emergency cardiac surgery. Data was reviewed from a prospectively entered unit?maintained cardiac surgery database. To ensure safe delivery of care to patients, a series of strict measures were implemented which included: a parallel healthcare system maintaining a COVID?19 cold site, social isolation of patients for one to 2 weeks before surgery, polymerase chain reaction testing for COVID?19, 72?hours before surgery, discrete staff assigned only to cardiac surgical cases socially isolated for 2 weeks as necessary. Results The mean age at surgery was 59.7?±?11 years and 41 (70.7%) were male. Fifty?two patients were hypertensive (90%), and 32 were diabetic (55.2%). There were three emergency type A aortic dissections. Forty?seven patients underwent coronary artery bypass graft surgery with all but three performed off?pump. Fourteen cases required blood product transfusion. One patient had postoperative pneumonia associated with chronic obstructive pulmonary disease. The median length of stay was 5.7?±?1.8 days. All patients were discharged home after rehabilitation. There were no cases of COVID?19 infection among healthcare workers during the study period. Conclusion These strategies allowed us to maintain a service for urgent and emergency procedures and may prove useful for larger countries when there is decrease in COVID?19 cases and planning for the restart of elective cardiac surgery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7461539/ 1330 0886-0440 Journal of cardiac surgery Hoboken, NJ : Wiley-Blackwell.
17887 114788 MERS patient Patient patient abstract 환자 60931 https://doi.org/10.1111/jocs.14975 Adult cardiac surgery in Trinidad and Tobago during the COVID?19 pandemic: Lessons from a developing country Richard A. E. Ramsingh|||Jean?Luc Duval|||Natasha C. Rahaman|||Risshi D. Rampersad|||Gianni D. Angelini|||Giovanni Teodori 202008 Original Article PMC Abstract Background and Aim The coronavirus disease 2019 (COVID?19) pandemic has seen the cancellation of elective cardiac surgeries worldwide. Here we report the experience of a cardiac surgery unit in a developing country in response to the COVID?19 crisis. Methods From 6th April to 12th June 2020, 58 patients underwent urgent or emergency cardiac surgery. Data was reviewed from a prospectively entered unit?maintained cardiac surgery database. To ensure safe delivery of care to patients, a series of strict measures were implemented which included: a parallel healthcare system maintaining a COVID?19 cold site, social isolation of patients for one to 2 weeks before surgery, polymerase chain reaction testing for COVID?19, 72?hours before surgery, discrete staff assigned only to cardiac surgical cases socially isolated for 2 weeks as necessary. Results The mean age at surgery was 59.7?±?11 years and 41 (70.7%) were male. Fifty?two patients were hypertensive (90%), and 32 were diabetic (55.2%). There were three emergency type A aortic dissections. Forty?seven patients underwent coronary artery bypass graft surgery with all but three performed off?pump. Fourteen cases required blood product transfusion. One patient had postoperative pneumonia associated with chronic obstructive pulmonary disease. The median length of stay was 5.7?±?1.8 days. All patients were discharged home after rehabilitation. There were no cases of COVID?19 infection among healthcare workers during the study period. Conclusion These strategies allowed us to maintain a service for urgent and emergency procedures and may prove useful for larger countries when there is decrease in COVID?19 cases and planning for the restart of elective cardiac surgery. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/7461539/ 1330 0886-0440 Journal of cardiac surgery Hoboken, NJ : Wiley-Blackwell.
18057 114788 MERS discharge rate Term discharge rate abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
18063 114788 MERS executive Term executive abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
18064 114788 MERS experimental Term experimental abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
18065 114788 MERS expert consensus Term expert consensus abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
18066 114788 MERS facilitator Term facilitator abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
18078 114788 MERS lack Action lack abstract 62167 https://doi.org/10.2196/30453 Digital Orientation of Health Systems in the Post?COVID-19 “New Normal” in the United States: Cross-sectional Survey Jiban Khuntia|||Xue Ning|||Rulon Stacey 202108 Original Paper PMC Background Almost all health systems have developed some form of customer-facing digital technologies and have worked to align these systems to their existing electronic health records to accommodate the surge in remote and virtual care deliveries during the COVID-19 pandemic. Others have developed analytics-driven decision-making capabilities. However, it is not clear how health systems in the United States are embracing digital technologies and there is a gap in health systems’ abilities to integrate workflows with expanding technologies to spur innovation and futuristic growth. There is a lack of reliable and reported estimates of the current and futuristic digital orientations of health systems. Periodic assessments will provide imperatives to policy formulation and align efforts to yield the transformative power of emerging digital technologies. Objective The aim of this study was to explore and examine differences in US health systems with respect to digital orientations in the post?COVID-19 “new normal” in 2021. Differences were assessed in four dimensions: (1) analytics-oriented digital technologies (AODT), (2) customer-oriented digital technologies (CODT), (3) growth and innovation?oriented digital technologies (GODT), and (4) futuristic and experimental digital technologies (FEDT). The former two dimensions are foundational to health systems’ digital orientation, whereas the latter two will prepare for future disruptions. Methods We surveyed a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (22%) responded to our survey. We considered the above four broad digital technology orientations, which were ratified with expert consensus. Secondary data were collected from the Agency for Healthcare Research and Quality Hospital Compendium, leading to a matched usable dataset of 124 health systems for analysis. We examined the relationship of adopting the four digital orientations to specific hospital characteristics and earlier reported factors as barriers or facilitators to technology adoption. Results Health systems showed a lower level of CODT (mean 4.70) or GODT (mean 4.54) orientations compared with AODT (mean 5.03), and showed the lowest level of FEDT orientation (mean 4.31). The ordered logistic estimation results provided nuanced insights. Medium-sized ( P <.001) health systems, major teaching health systems ( P <.001), and systems with high-burden hospitals ( P <.001) appear to be doing worse with respect to AODT orientations, raising some concerns. Health systems of medium ( P <.001) and large ( P =.02) sizes, major teaching health systems ( P =.07), those with a high revenue ( P =.05), and systems with high-burden hospitals ( P <.001) have less CODT orientation. Health systems in the midwest ( P =.05) and southern ( P =.04) states are more likely to adopt GODT, whereas high-revenue ( P =.004) and investor-ownership ( P =.01) health systems are deterred from GODT. Health systems of a medium size, and those that are in the midwest ( P <.001), south ( P <.001), and west ( P =.01) are more adept to FEDT, whereas medium ( P <.001) and high-revenue ( P <.001) health systems, and those with a high discharge rate ( P =.04) or high burden ( P =.003, P =.005) have subdued FEDT orientations. Conclusions Almost all health systems have some current foundational digital technological orientations to glean intelligence or service delivery to customers, with some notable exceptions. Comparatively, fewer health systems have growth or futuristic digital orientations. The transformative power of digital technologies can only be leveraged by adopting futuristic digital technologies. Thus, the disparities across these orientations suggest that a holistic, consistent, and well-articulated direction across the United States remains elusive. Accordingly, we suggest that a policy strategy and financial incentives are necessary to spur a well-visioned and articulated digital orientation for all health systems across the United States. In the absence of such a policy to collectively leverage digital transformations, differences in care across the country will continue to be a concern. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8370259/ 88 1439-4456 Journal of Medical Internet Research Toronto : JMIR Publications.
17800 114788 MERS Community health services Term community health service author 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
17802 114788 MERS contagion Term contagion abstract 접촉감염 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
17812 114788 MERS inherent Term inherent abstract 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
17815 114788 MERS mean Term mean abstract 평균 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
17817 114788 MERS midwive Term midwive abstract 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
17819 114788 MERS nucleus Molecule nucleus abstract 핵 60264 https://doi.org/10.1186/s13006-022-00453-0 Breastfeeding experiences during the COVID-19 pandemic in Spain:a qualitative study Isabel Rodr?guez-Gallego|||Helen Strivens-Vilchez|||Irene Agea-Cano|||Carmen Mar?n-S?nchez|||Mar?a Dolores Sevillano-Giraldo|||Concepci?n Gamundi-Fern?ndez|||Concepci?n Bern?-Guisado|||Fatima Leon-Larios 202202 Research PMC Background The pandemic caused by COVID-19 has affected reproductive and perinatal health both through the infection itself and, indirectly, as a consequence of changes in medical care, social policy or social and economic circumstances. The objective of this study is to explore the impact of the pandemic and of the measures adopted on breastfeeding initiation and maintenance. Methods A qualitative descriptive study was conducted by means in-depth semi-structured interviews, until reaching data saturation. The study was conducted between the months of January to May 2021. Participants were recruited by midwives from the Primary Care Centres of the Andalusian provinces provinces of Seville, C?diz, Huelva, Granada, and Ja?n. The interviews were conducted via phone call and were subsequently transcribed and analysed by means of reflexive inductive thematic analysis, using Braun and Clarke’s thematic analysis. Results A total of 30 interviews were conducted. Five main themes and ten subthemes were developed, namely: Information received (access to the information, figure who provided the information), unequal support from the professionals during the pandemic (support to postpartum hospitalization, support received from Primary Health Care during the postpartum period), social and family support about breastfeeding (support groups, family support), impact of confinement and of social restriction measures (positive influence on breastfeeding, influence on bonding with the newborn), emotional effect of the pandemic (insecurity and fear related to contagion by coronavirus, feelings of loneliness). Conclusion The use of online breastfeeding support groups through applications such as WhatsApp®, Facebook® or Instagram® has provided important breastfeeding information and support sources. The main figure identified that has provided formal breastfeeding support during this period was that of the midwife. In addition, the social restrictions inherent to the pandemic have exerted a positive effect for women in bonding and breastfeeding, as a consequence of the increase in the time spent at their homes and in the family nucleus co-living. Supplementary Information The online version contains supplementary material available at 10.1186/s13006-022-00453-0. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC/8861604/ 2266 International Breastfeeding Journal
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