@article{47d0e31e621948e08af057a393eb67ab,
title = "Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients",
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.",
author = "Joyner, {Michael J.} and Bruno, {Katelyn A.} and Klassen, {Stephen A.} and Kunze, {Katie L.} and Johnson, {Patrick W.} and Lesser, {Elizabeth R.} and Wiggins, {Chad C.} and Senefeld, {Jonathon W.} and Klompas, {Allan M.} and Hodge, {David O.} and Shepherd, {John R.A.} and Rea, {Robert F.} and Whelan, {Emily R.} and Clayburn, {Andrew J.} and Spiegel, {Matthew R.} and Baker, {Sarah E.} and Larson, {Kathryn F.} and Ripoll, {Juan G.} and Andersen, {Kylie J.} 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 {van Helmond}, Noud and Butterfield, {Brian P.} and Sexton, {Matthew A.} and {Diaz Soto}, {Juan C.} and Paneth, {Nigel S.} and Verdun, {Nicole C.} and Peter Marks and Arturo Casadevall and Fairweather, {De Lisa} and Carter, {Rickey E.} and Wright, {R. Scott}",
note = "Funding Information: Grant Support: This study was supported in part by a U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) contract 75A50120C00096 (to M.J.J.), National Center for Advancing Translational Sciences (NCATS) grant UL1TR002377 , National Heart, Lung, and Blood Institute (NHLBI) grant 5R35HL139854 (to MJJ), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5T32DK07352 (to J.W.S. and C.C.W.), Natural Sciences and Engineering Research Council of Canada (NSERC) PDF- 532926-2019 (to S.A.K.), National Institute of Allergy and Infectious Disease (NIAID) grants R21 AI145356 and R21 AI152318 (to D.F.), R01 AI152078 9 (to A.C.), National Heart, Lung, and Blood Institute RO1 HL059842 (to A.C.), National Institute on Aging (NIA) U54AG044170 (to S.E.B.), Schwab Charitable Fund (Eric E. Schmidt, Wendy Schmidt donors), United Health Group, National Basketball Association (NBA), Millennium Pharmaceuticals, Octapharma USA, Inc., and the Mayo Clinic. Funding Information: Grant Support: This study was supported in part by a U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) contract 75A50120C00096 (to M.J.J.), National Center for Advancing Translational Sciences (NCATS) grant UL1TR002377, National Heart, Lung, and Blood Institute (NHLBI) grant 5R35HL139854 (to MJJ), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5T32DK07352 (to J.W.S. and C.C.W.), Natural Sciences and Engineering Research Council of Canada (NSERC) PDF-532926-2019 (to S.A.K.), National Institute of Allergy and Infectious Disease (NIAID) grants R21 AI145356 and R21 AI152318 (to D.F.), R01 AI152078 9 (to A.C.), National Heart, Lung, and Blood Institute RO1 HL059842 (to A.C.), National Institute on Aging (NIA) U54AG044170 (to S.E.B.), Schwab Charitable Fund (Eric E. Schmidt, Wendy Schmidt donors), United Health Group, National Basketball Association (NBA), Millennium Pharmaceuticals, Octapharma USA, Inc., and the Mayo Clinic.The authors thank the dedicated members of the US Convalescent Plasma Expanded Access Program team ? Machiko Anderson, Supriya Behl, Lori Bergstrom, Brian Butterfield, Grant Dubbels, Adam Eggert, Ree Erickson, Rebekah Frost, Daniel Gaz, Winston Guo, Starr Guzman, Karina Hex, Vidhu Joshi, Megan Knudson, Tessa Kroeninger, Frances Lynch, Tim Miksch, Lisa Muenkel, Ryan Oldenburg, Amy Olofson, Laura Pacheco-Spann, Dr Kelly Paulson, Dr Sumedha Penheiter, Melanie Peterson, Katrina Pierce, Nicloas Saikali, Jeffrey Schmoll, Pamela Skaran, Lindsay Stromback, Edward Swaray, Morgan Swope, Kristine Tree, Joe Wick, and Janelle Worthington; the members of the Mayo Clinic Institutional Review Board; the Mayo Clinic Office of Human Research Protection; the Mayo Clinic Office of Research Regulatory Support, and in particular Mark Wentworth. The authors thank the Executive Dean of Research at Mayo Clinic, Dr Gregory Gores, and the CEO of Mayo Clinic, Dr Gianrico Farrugia, for their support and assistance; the independent Data and Safety Monitoring Board for their work and oversight of the Expanded Access Program ? Drs Allan S. Jaffe (chair), David O. Warner, William G. Morice II, Paula J. Santrach, Robert L. Frye, Lawrence J Appel, and Taimur Sher; the members of the National COVID-19 Convalescent Plasma Project (http://ccpp19.org) for their intellectual contributions and support; the participating medical centers and medical teams and blood centers for their rigorous efforts necessary to make this program possible; the donors for providing COVID-19 convalescent plasma; Drs Joyner, Bruno, Klassen, Kunze, Johnson, Lesser, Wiggins, Senefeld, and Klompas are co-first authors. Drs Paneth, Verdun, Marks, Casadevall, Fairweather, Carter, and Wright are co-senior authors. Publisher Copyright: {\textcopyright} 2020",
year = "2020",
month = sep,
doi = "10.1016/j.mayocp.2020.06.028",
language = "English (US)",
volume = "95",
pages = "1888--1897",
journal = "Mayo Clinic proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "9",
}