Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults

Type Journal Article Author Romina Libster Author Gonzalo Pérez Marc Author Diego Wappner Author Silvina Coviello Author Alejandra Bianchi Author Virginia Braem Author Ignacio Esteban Author Mauricio T. Caballero Author Cristian Wood Author Mabel Berrueta Author Aníbal Rondan Author Gabriela Lescano Author Pablo Cruz Author Yvonne Ritou Author Valeria Fernández Viña Author Damián Álvarez Paggi Author Sebastián Esperante Author Adrián Ferreti Author Gastón Ofman Author Álvaro Ciganda Author Rocío Rodriguez Author Jorge Lantos Author Ricardo Valentini Author Nicolás Itcovici Author Alejandra Hintze Author M. Laura Oyarvide Author Candela Etchegaray Author Alejandra Neira Author Ivonne Name Author Julieta Alfonso Author Rocío López Castelo Author Gisela Caruso Author Sofía Rapelius Author Fernando Alvez Author Federico Etchenique Author Federico Dimase Author Darío Alvarez Author Sofía S. Aranda Author Clara Sánchez Yanotti Author Julián De Luca Author Sofía Jares Baglivo Author Sofía Laudanno Author Florencia Nowogrodzki Author Ramiro Larrea Author María Silveyra Author Gabriel Leberzstein Author Alejandra Debonis Author Juan Molinos Author Miguel González Author Eduardo Perez Author Nicolás Kreplak Author Susana Pastor Argüello Author Luz Gibbons Author Fernando Althabe Author Eduardo Bergel Author Fernando P. Polack URL https://www.nejm.org/doi/10.1056/NEJMoa2033700 Rights Copyright © 2021 Massachusetts Medical Society. All rights reserved. Publication New England Journal of Medicine Date 06/01/2021 Loc. in Archive world Extra Publisher: Massachusetts Medical Society DOI 10.1056/NEJMoa2033700 Library Catalog www.nejm.org Language en Abstract Background Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. Methods We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible. Results A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P=0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed.