Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.

Autor:	Joyner MJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN. Electronic address: https://twitter.com/DrMJoyner., Bruno KA; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL., Klassen SA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Kunze KL; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ., Johnson PW; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL., Lesser ER; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL., Wiggins CC; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Senefeld JW; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Klompas AM; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Hodge DO; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL., Shepherd JRA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Rea RF; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN., Whelan ER; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL., Clayburn AJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Spiegel MR; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL., Baker SE; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Larson KF; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Ripoll JG; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Andersen KJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Buras MR; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ., Vogt MNP; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Herasevich V; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Dennis JJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Regimbal RJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Bauer PR; Department of Internal Medicine, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester, MN., Blair JE; Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix, AZ., van Buskirk CM; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN., Winters JL; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN., Stubbs JR; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN., van Helmond N; Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ., Butterfield BP; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Sexton MA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Diaz Soto JC; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN., Paneth NS; Departments of Epidemiology and Biostatistics and Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing., Verdun NC; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Marks P; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Casadevall A; Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD., Fairweather D; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL., Carter RE; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL., Wright RS; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Department of Human Research Protection Program, Mayo Clinic, Rochester, MN.
Jazyk:	angličtina
Zdroj:	Mayo Clinic proceedings [Mayo Clin Proc] 2020 Sep; Vol. 95 (9), pp. 1888-1897. Date of Electronic Publication: 2020 Jul 19.
DOI:	10.1016/j.mayocp.2020.06.028
Abstrakt:	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. (Copyright © 2020. Published by Elsevier Inc.)
Databáze:	MEDLINE
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