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

Joyner, Michael J.; Bruno, Katelyn A.; Klassen, Stephen A.; Kunze, Katie L.; Johnson, Patrick W.; Lesser, Elizabeth R.; Wiggins, Chad C.; Senefeld, Jonathon W.; Klompas, Allan M.; Hodge, David O.; Shepherd, John R.A.; Rea, Robert F.; Whelan, Emily R.; Clayburn, Andrew J.; Spiegel, Matthew R.; Baker, Sarah E.; Larson, Kathryn F.; Ripoll, Juan G.; Andersen, Kylie J.; Buras, Matthew R.; Vogt, Matthew N.P.; Herasevich, Vitaly; Dennis, Joshua J.; Regimbal, Riley J.; Bauer, Philippe R.; Blair, Janis E.; Van Buskirk, Camille M.; Winters, Jeffrey L.; Stubbs, James R.; van Helmond, Noud; Butterfield, Brian P.; Sexton, Matthew A.; Diaz Soto, Juan C.; Paneth, Nigel S.; Verdun, Nicole C.; Marks, Peter; Casadevall, Arturo; Fairweather, DeLisa; Carter, Rickey E.; Wright, R. Scott

Abstract Objective To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized COVID-19 patients, having previously demonstrated safety in 5,000 hospitalized patients. Patients and Methods From April 3 to June 2, 2020, the US FDA 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=89; <1%), thromboembolic or thrombotic events (n=87; <1%), and cardiac events (n=680, ∼3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=55) and cardiac events (n=562) were judged to be unrelated to the plasma transfusion per se. The seven-day mortality rate was 8.6% (8.2%, 9.0%), and was higher among more critically-ill patients relative to less ill counterparts, including patients admitted to the intensive care unit vs. not admitted (10.5% vs. 6.0%), mechanically ventilated vs. not ventilated (12.1% vs. 6.2%), and with septic shock or multiple organ dysfunction/failure vs. those without dysfunction/failure (14.0% vs. 7.6%). 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.