Safety Update

• Published in: Mayo Clinic proceedings Vol. 95; no. 9; pp. 1888 - 1897
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2020
• Subjects: COVID-19; FDA; EAP; TRALI; SAE; IRB; ICU; TACO
• ISSN: 0025-6196; 1942-5546
• DOI: 10.1016/j.mayocp.2020.06.028

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. 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. 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%). 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.