TY - JOUR
T1 - Convalescent Plasma for Covid-19-Induced ARDS in Mechanically Ventilated Patients
AU - Misset, Benoît
AU - Piagnerelli, Michael
AU - Hoste, Eric
AU - Dardenne, Nadia
AU - Grimaldi, David
AU - Michaux, Isabelle
AU - De Waele, Elisabeth
AU - Dumoulin, Alexander
AU - Jorens, Philippe G
AU - van der Hauwaert, Emmanuel
AU - Vallot, Frédéric
AU - Lamote, Stoffel
AU - Swinnen, Walter
AU - De Schryver, Nicolas
AU - Fraipont, Vincent
AU - de Mey, Nathalie
AU - Dauby, Nicolas
AU - Layios, Nathalie
AU - Mesland, Jean-Baptiste
AU - Meyfroidt, Geert
AU - Moutschen, Michel
AU - Compernolle, Veerle
AU - Gothot, André
AU - Desmecht, Daniel
AU - Taveira da Silva Pereira, Maria I
AU - Garigliany, Mutien
AU - Najdovski, Tome
AU - Bertrand, Axelle
AU - Donneau, Anne-Françoise
AU - Laterre, Pierre-François
N1 - Copyright © 2023 Massachusetts Medical Society.
PY - 2023/10/26
Y1 - 2023/10/26
N2 - 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.).
AB - 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.).
KW - Adult
KW - Humans
KW - Antibodies, Neutralizing/immunology
KW - COVID-19/complications
KW - COVID-19 Serotherapy
KW - Respiration, Artificial
KW - Respiratory Distress Syndrome/etiology
KW - SARS-CoV-2
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85175404510&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2209502
DO - 10.1056/NEJMoa2209502
M3 - Article
C2 - 37889107
SN - 0028-4793
VL - 389
SP - 1590
EP - 1600
JO - The New England journal of medicine
JF - The New England journal of medicine
IS - 17
ER -