Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients
Michael J Joyner, Katelyn A Bruno, Stephen A Klassen, Katie L Kunze, Patrick W Johnson, Elizabeth R Lesser, Chad C Wiggins, Jonathon W Senefeld, Allan M Klompas, David O Hodge, John R A Shepherd, Robert F Rea, Emily R Whelan, Andrew J Clayburn, Matthew R Spiegel, Sarah E Baker, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Matthew R Buras, Matthew N P Vogt, Vitaly Herasevich, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Camille M van Buskirk, Jeffrey L Winters, James R Stubbs, Noud van Helmond, Brian P Butterfield, Matthew A Sexton, Juan C Diaz Soto, Nigel S Paneth, Nicole C Verdun, Peter Marks, Arturo Casadevall, DeLisa Fairweather, Rickey E Carter, R Scott Wright, Michael J Joyner, Katelyn A Bruno, Stephen A Klassen, Katie L Kunze, Patrick W Johnson, Elizabeth R Lesser, Chad C Wiggins, Jonathon W Senefeld, Allan M Klompas, David O Hodge, John R A Shepherd, Robert F Rea, Emily R Whelan, Andrew J Clayburn, Matthew R Spiegel, Sarah E Baker, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Matthew R Buras, Matthew N P Vogt, Vitaly Herasevich, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Camille M van Buskirk, Jeffrey L Winters, James R Stubbs, Noud van Helmond, Brian P Butterfield, Matthew A Sexton, Juan C Diaz Soto, Nigel S Paneth, Nicole C Verdun, Peter Marks, Arturo Casadevall, DeLisa Fairweather, Rickey E Carter, R Scott Wright
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.
Copyright © 2020. Published by Elsevier Inc.
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Source: PubMed