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Mayo Clin Proc
. 2020 Sep;95(9):1888-1897.
doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients
Michael J Joyner 1 , Katelyn A Bruno 2 , Stephen A Klassen 3 , Katie L Kunze 4 , Patrick W Johnson 5 , Elizabeth R Lesser 5 , Chad C Wiggins 3 , Jonathon W Senefeld 3 , Allan M Klompas 3 , David O Hodge 5 , John R A Shepherd 3 , Robert F Rea 6 , Emily R Whelan 2 , Andrew J Clayburn 3 , Matthew R Spiegel 5 , Sarah E Baker 3 , Kathryn F Larson 3 , Juan G Ripoll 3 , Kylie J Andersen 3 , Matthew R Buras 4 , Matthew N P Vogt 3 , Vitaly Herasevich 3 , Joshua J Dennis 3 , Riley J Regimbal 3 , Philippe R Bauer 7 , Janis E Blair 8 , Camille M van Buskirk 9 , Jeffrey L Winters 9 , James R Stubbs 9 , Noud van Helmond 10 , Brian P Butterfield 3 , Matthew A Sexton 3 , Juan C Diaz Soto 3 , Nigel S Paneth 11 , Nicole C Verdun 12 , Peter Marks 12 , Arturo Casadevall 13 , DeLisa Fairweather 2 , Rickey E Carter 5 , R Scott Wright 14
Affiliations
- PMID: 32861333
- DOI: 10.1016/j.mayocp.2020.06.028
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.