Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients
Michael Joyner, R Scott Wright, DeLisa Fairweather, Jonathon Senefeld, Katelyn Bruno, Stephen Klassen, Rickey Carter, Allan Klompas, Chad Wiggins, John Ra Shepherd, Robert Rea, Emily Whelan, Andrew Clayburn, Matthew Spiegel, Patrick Johnson, Elizabeth Lesser, Sarah Baker, Kathryn Larson, Juan Ripoll Sanz, Kylie Andersen, David Hodge, Katie Kunze, Matthew Buras, Matthew Vogt, Vitaly Herasevich, Joshua Dennis, Riley Regimbal, Philippe Bauer, Janis Blair, Camille van Buskirk, Jeffrey Winters, James Stubbs, Nigel Paneth, Arturo Casadevall, Michael Joyner, R Scott Wright, DeLisa Fairweather, Jonathon Senefeld, Katelyn Bruno, Stephen Klassen, Rickey Carter, Allan Klompas, Chad Wiggins, John Ra Shepherd, Robert Rea, Emily Whelan, Andrew Clayburn, Matthew Spiegel, Patrick Johnson, Elizabeth Lesser, Sarah Baker, Kathryn Larson, Juan Ripoll Sanz, Kylie Andersen, David Hodge, Katie Kunze, Matthew Buras, Matthew Vogt, Vitaly Herasevich, Joshua Dennis, Riley Regimbal, Philippe Bauer, Janis Blair, Camille van Buskirk, Jeffrey Winters, James Stubbs, Nigel Paneth, Arturo Casadevall
Abstract
Background: Convalescent plasma is the only antibody based therapy currently available for COVID-19 patients. It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.
Methods: Thus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5,000 hospitalized adults with severe or life threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA Expanded Access Program for COVID-19 convalescent plasma.
Results: The incidence of all serious adverse events (SAEs) in the first four hours after transfusion was <1%, including mortality rate (0.3%). Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n=4), transfusion-associated circulatory overload (TACO; n=7), transfusion-related acute lung injury (TRALI; n=11), and severe allergic transfusion reactions (n=3). However, only 2 (of 36) SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The seven-day mortality rate was 14.9%.
Conclusion: Given the deadly nature of COVID-19 and the large population of critically-ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.
Source: PubMed