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. BurasMatthew 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, De Lisa Fairweather, Rickey E. Carter, R. Scott Wright

Research output: Contribution to journalArticlepeer-review

107 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1888-1897
Number of pages10
JournalMayo Clinic proceedings
Volume95
Issue number9
DOIs
StatePublished - Sep 2020

ASJC Scopus subject areas

  • Medicine(all)

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