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Convalescent Plasma for Covid-19-Induced ARDS in Mechanically Ventilated Patients

Benoît Misset¹, Michael Piagnerelli¹, Eric Hoste¹

¹From the Departments of Intensive Care Medicine (B.M., N.L., A.B.), Infectious Diseases (M.M.), Immunohematology (A.G.), and Microbiology (M.I.T.S.P.), University Hospital of Liège, the Biostatistics Unit, Public Health Department (N. Dardenne, A.-F.D.), and the Department of Animal Pathology (D.D., M.G.), Liège University, and the Department of Intensive Care Medicine, Citadelle General Hospital (V.F.), Liège, the Department of Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Charleroi-Marie Curie Hospital, Université Libre de Bruxelles, Charleroi (M.P.), the Department of Intensive Care Medicine, Ghent University Hospital (E. Hoste), and the Faculty of Medicine and Health Sciences (V.C.), Ghent University, Ghent, the Department of Intensive Care Medicine, Cliniques Universitaires de Bruxelles-Erasme, Université Libre de Bruxelles (D.G.), the Division of Infectious Diseases, Saint-Pierre University Hospital (N. Dauby), and the Department of Intensive Care Medicine, Saint-Luc University Hospital (J.-B.M., P.-F.L.), Brussels, the Department of Intensive Care, Université Catholique de Louvain (UCL), CHU UCL Namur, Yvoir (I.M.), the Department of Intensive Care Medicine, Brussels University Hospital, Vrije Universiteit Brussel, Jette (E.D.W.), the Department of Intensive Care Medicine, Delta General Hospital, Roeselare (A.D.), the Department of Intensive Care Medicine, Antwerp University Hospital, University of Antwerp, Edegem (P.G.J.), the Department of Intensive Care Medicine, Imelda General Hospital, Bonheiden (E. Hauwaert), the Department of Intensive Care Medicine, Wallonie Picarde General Hospital, Tournai (F.V.), the Department of Intensive Care Medicine, Groeninge General Hospital, Kortrijk (S.L.), the Department of Intensive Care Medicine, Sint Blasius General Hospital, Dendermonde (W.S.), the Department of Intensive Care Medicine, Saint-Pierre Medical Clinic, Ottignies (N.D.S.), the Department of Intensive Care Medicine, Onze-Lieve-Vrouw General Hospital, Aalst (N.M.), the Department of Intensive Care Medicine, University Hospitals Leuven, Leuven (G.M.), Blood Services from the Red Cross, Mechelen (V.C.), Blood Services from the Red Cross, Suarlée (T.N.), and the Department of Intensive Care Medicine, Centre Hospitalier Régional Mons-Hainaut, Mons (P.-F.L.) - all in Belgium.

The New England Journal of Medicine

|October 27, 2023

Abstract

Background:

Passive immunization with plasma collected from convalescent patients has been regularly used to treat coronavirus disease 2019 (Covid-19). Minimal data are available regarding the use of convalescent plasma in patients with Covid-19-induced acute respiratory distress syndrome (ARDS).

Methods:

In this open-label trial, we randomly assigned adult patients with Covid-19-induced ARDS who had been receiving invasive mechanical ventilation for less than 5 days in a 1:1 ratio to receive either convalescent plasma with a neutralizing antibody titer of at least 1:320 or standard care alone. Randomization was stratified according to the time from tracheal intubation to inclusion. The primary outcome was death by day 28.

Results:

A total of 475 patients underwent randomization from September 2020 through March 2022. Overall, 237 patients were assigned to receive convalescent plasma and 238 to receive standard care. Owing to a shortage of convalescent plasma, a neutralizing antibody titer of 1:160 was administered to 17.7% of the patients in the convalescent-plasma group. Glucocorticoids were administered to 466 patients (98.1%). At day 28, mortality was 35.4% in the convalescent-plasma group and 45.0% in the standard-care group (P = 0.03). In a prespecified analysis, this effect was observed mainly in patients who underwent randomization 48 hours or less after the initiation of invasive mechanical ventilation. Serious adverse events did not differ substantially between the two groups.

Conclusions:

The administration of plasma collected from convalescent donors with a neutralizing antibody titer of at least 1:160 to patients with Covid-19-induced ARDS within 5 days after the initiation of invasive mechanical ventilation significantly reduced mortality at day 28. This effect was mainly observed in patients who underwent randomization 48 hours or less after ventilation initiation. (Funded by the Belgian Health Care Knowledge Center; ClinicalTrials.gov number, NCT04558476.).

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