Journal
MAYO CLINIC PROCEEDINGS
Volume 95, Issue 9, Pages 1888-1897Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.mayocp.2020.06.028
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Funding
- U.S. Department of Health and Human Services (HHS)
- Biomedical Advanced Research and Development Authority (BARDA) [75A50120C00096]
- National Center for Advancing Translational Sciences (NCATS) [UL1TR002377]
- National Heart, Lung, and Blood Institute (NHLBI) [5R35HL139854]
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [5T32DK07352]
- Natural Sciences and Engineering Research Council of Canada (NSERC) [PDF-532926-2019]
- National Institute of Allergy and Infectious Disease (NIAID) [R21 AI145356, R21 AI152318, R01 AI152078 9]
- National Heart, Lung, and Blood Institute [RO1 HL059842]
- National Institute on Aging (NIA) [U54AG044170]
- Schwab Charitable Fund
- United Health Group
- National Basketball Association (NBA)
- Millennium Pharmaceuticals
- Octapharma USA, Inc.
- Mayo Clinic
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Objective: To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients. Patients and Methods: From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma. Results: The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, similar to 3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%). Conclusion: These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality. (C) 2020 Mayo Foundation for Medical Education and Research
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