Elsevier

Mayo Clinic Proceedings

Volume 95, Issue 9, September 2020, Pages 1888-1897
Mayo Clinic Proceedings

Original article
Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients

https://doi.org/10.1016/j.mayocp.2020.06.028Get rights and content

Abstract

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, ~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.

Abbreviations and Acronyms

COVID-19
coronavirus disease 2019
EAP
Expanded Access Program
FDA
Food and Drug Administration
ICU
intensive care unit
IRB
Institutional Review Board
SAE
serious adverse event
TACO
transfusion-associated circulatory overload
TRALI
transfusion-related acute lung injury

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For editorial comment, see page 1813

Grant Support: This study was supported in part by a U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) contract 75A50120C00096 (to M.J.J.), National Center for Advancing Translational Sciences (NCATS) grant UL1TR002377, National Heart, Lung, and Blood Institute (NHLBI) grant 5R35HL139854 (to MJJ), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5T32DK07352 (to J.W.S. and C.C.W.), Natural Sciences and Engineering Research Council of Canada (NSERC) PDF-532926-2019 (to S.A.K.), National Institute of Allergy and Infectious Disease (NIAID) grants R21 AI145356 and R21 AI152318 (to D.F.), R01 AI152078 9 (to A.C.), National Heart, Lung, and Blood Institute RO1 HL059842 (to A.C.), National Institute on Aging (NIA) U54AG044170 (to S.E.B.), Schwab Charitable Fund (Eric E. Schmidt, Wendy Schmidt donors), United Health Group, National Basketball Association (NBA), Millennium Pharmaceuticals, Octapharma USA, Inc., and the Mayo Clinic.

Potential Competing Interests: The authors report no potential competing interests.

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