Early safety indicators of COVID-19 convalescent plasma in 5000 patients

BACKGROUNDConvalescent 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.METHODSThus, 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.RESULTSThe incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first…

• UD
  U.S. Department of Health and Human Services

  Award: 75A50120C00096
• MC
  Mayo Clinic

  Awards: UL1TR002377, 55905
• TO
  Takeda Oncology
• BA
  Biomedical Advanced Research and Development Authority

  Award: 75A50120C00096
• NS
  Natural Sciences and Engineering Research Council of Canada

  Awards: R21 AI145356, PDF-532926-2019, R21 AI152318, 5R35HL139854, 5T32DK07352, R01 HL059842, 532926-2019, R01 AI1520789
• NH
  National Heart, Lung, and Blood Institute

  Awards: AI152078, PDF-532926-2019, 5R35HL139854, 5T32DK07352, R01 AI1520789, HL059842, R21 AI145356, R01 HL059842, R21 AI152318
• NI
  National Institute of Diabetes and Digestive and Kidney Diseases

  Awards: R21 AI145356, R21 AI152318, 5R35HL139854, R01 HL059842, 5T32DK07352, R01 AI1520789, PDF-532926-2019
• NC
  National Center for Advancing Translational Sciences

  Award: UL1TR002377