[HTML][HTML] Early safety indicators of COVID-19 convalescent plasma in 5000 patients
The Journal of clinical investigation, 2020•Am Soc Clin Investig
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 …
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 …
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.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04338360.
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.
The Journal of Clinical Investigation