@article{07265d110e2c4f38a6301c0c0e16c414,
title = "Early safety indicators of COVID-19 convalescent plasma in 5000 patients",
abstract = "BACKGROUND. Convalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 (COVID-19). 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 5000 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), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (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 7-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.",
author = "Joyner, {Michael J.} and Wright, {R. Scott} and Delisa Fairweather and Senefeld, {Jonathon W.} and Bruno, {Katelyn A.} and Klassen, {Stephen A.} and Carter, {Rickey E.} and Klompas, {Allan M.} and Wiggins, {Chad C.} and Shepherd, {John R.A.} and Rea, {Robert F.} and Whelan, {Emily R.} and Clayburn, {Andrew J.} and Spiegel, {Matthew R.} and Johnson, {Patrick W.} and Lesser, {Elizabeth R.} and Baker, {Sarah E.} and Larson, {Kathryn F.} and Ripoll, {Juan G.} and Andersen, {Kylie J.} and Hodge, {David O.} and Kunze, {Katie L.} and Buras, {Matthew R.} and Vogt, {Matthew N.P.} and Vitaly Herasevich and Dennis, {Joshua J.} and Regimbal, {Riley J.} and Bauer, {Philippe R.} and Blair, {Janis E.} and {Van Buskirk}, {Camille M.} and Winters, {Jeffrey L.} and Stubbs, {James R.} and Paneth, {Nigel S.} and Verdun, {Nicole C.} and Peter Marks and Arturo Casadevall",
note = "Funding Information: This study was supported in part by a US Department of Health and Human Services Biomedical Advanced Research and Development Authority contract (75A50120C00096, to MJJ), a National Center for Advancing Translational Sciences grant (UL1TR002377), a National Heart, Lung, and Blood Institute grant (5R35HL139854, to MJJ), the National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352, to JWS and CCW), the Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019, to SAK), the National Institute of Allergy and Infectious Disease (R21 AI145356 and R21 AI152318, to DF; R01 AI1520789, to AC), the National Heart, Lung, and Blood Institute (R01 HL059842, to AC), the Schwab Charitable Fund (Eric E. Schmidt and Wendy Schmidt donors), the United Health Group, the National Basketball Association, Millennium Pharmaceuticals, Octapharma USA Inc., and the Mayo Clinic. We thank the members of the Mayo Clinic IRB, the Mayo Clinic Office of Human Research Protection; the Mayo Clinic Office of Research Regulatory Support and in particular Mark Wentworth; the Executive Dean of Research at Mayo Clinic, Gregory Gores, and the CEO of Mayo Clinic, Gianrico Farrugia, for their support and assistance; and the independent Data and Safety Monitoring Board for their work and oversight of the EAP, Allan S. Jaffe (chair), David O. Warner, William G. Morice II, Paula J. Santrach, Robert L. Frye, Lawrence J Appel, and Taimur Sher. We thank the members of the National COVID-19 Convalescent Plasma Project (http://ccpp19.org) for their intellectual contributions and support. We thank the participating medical centers and medical teams and blood centers for their rigorous efforts necessary to make this program possible. We also thank the donors for providing COVID-19 convalescent plasma. Funding Information: FUNDING. Mayo Clinic, Biomedical Advanced Research and Development Authority (75A50120C00096), National Center for Advancing Translational Sciences (UL1TR002377), National Heart, Lung, and Blood Institute (5R35HL139854 and R01 HL059842), National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352), Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019), National Institute of Allergy and Infectious Disease (R21 AI145356, R21 AI152318, and AI152078), Schwab Charitable Fund, United Health Group, National Basketball Association, Millennium Pharmaceuticals, and Octapharma USA Inc. Publisher Copyright: {\textcopyright} 2020, American Society for Clinical Investigation.",
year = "2020",
month = sep,
day = "1",
doi = "10.1172/JCI140200",
language = "English (US)",
volume = "130",
pages = "4791--4797",
journal = "Journal of Clinical Investigation",
issn = "0021-9738",
publisher = "The American Society for Clinical Investigation",
number = "9",
}