Design of VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1): A double-blind, randomized placebo-controlled trial of COVID-19 convalescent plasma in hospitalized patients with early respiratory compromise

Autor: Edward N. Janoff, Sheldon T. Brown, Ilana Belitskaya-Levy, Jeffrey L. Curtis, Robert A. Bonomo, Elliott K. Miller, Alexa M. Goldberg, Lisa Zehm, Ashlea Wills, Caitlin Hutchinson, Larry J. Dumont, Theresa Gleason, Mei-Chiung Shih
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Contemporary Clinical Trials Communications, Vol 35, Iss , Pp 101190- (2023)
Druh dokumentu: article
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2023.101190
Popis: Background: Effective therapeutics for severe acute respiratory syndrome CoronaVirus-2 (SARS-CoV-2) infection are evolving. Under Emergency Use Authorization, COVID-19 convalescent plasma (CCP) was widely used in individuals hospitalized for COVID-19, but few randomized controlled trials supported its efficacy to limit respiratory failure or death. Methods: VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1) was a double-blind, multi-site, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of CCP with conventional therapy in hospitalized Veterans with SARS-CoV-2 infection and early respiratory compromise (requirement for oxygen). Participants (planned sample size 702) were randomized 1:1 to receive CCP with high titer neutralizing activity or 0.9% saline, stratified by site and age (≥65 versus
Databáze: Directory of Open Access Journals