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Accès ouvert déclaré 2021 article

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial

276Citations signalées — pas une note de qualité
71Institutions déclarées
3Pays d’affiliation déclarés

Résumé fourni par la source

The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

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Contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref
Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial
Date Crossref
09/09/2021
Éditeur
Springer Science and Business Media LLC
Type
journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.

Institutions déclarées

Centre Hospitalier Universitaire Sainte-JustineCentre Hospitalier de l’Université de MontréalSunnybrook Health Science CentreQueen's UniversityPublic Health OntarioKingston Health Sciences CentreCanadian Blood ServicesMcMaster UniversityUniversity of WaterlooUniversity of OttawaOttawa HospitalOttawa Hospital Research InstituteUniversité de MontréalHemorioHéma-QuébecCornell UniversityWeill Cornell MedicineUniversity of TorontoHealth Sciences CentreUniversity of British ColumbiaCentre intégré de santé et de services sociaux de Chaudière-AppalachesUniversité LavalUniversity of CalgarySinai Health SystemNew York Blood CenterImpactMount Sinai HospitalPublic Health Agency of CanadaUniversity of ManitobaNewYork–Presbyterian Brooklyn Methodist HospitalScarborough Health NetworkTrillium Health CentreHôpital du Sacré-Cœur de MontréalMarkham Stouffville HospitalRockyview General HospitalMcGill University Health CentreWindsor Regional HospitalNorth York General HospitalLondon Health Sciences CentreHôpital Charles-Le MoyneCentre Intégré de Santé et de Services Sociaux des LaurentidesLakeridge HealthGrand River HospitalUniversity of AlbertaRoyal Alexandra HospitalJewish General HospitalHamilton General HospitalInstitut universitaire de cardiologie et de pneumologie de QuébecNiagara Health SystemUniversity Health NetworkBausch Health (Canada)Cegep de Saint JeromeQueensway-Carleton HospitalCentre Hospitalier Universitaire de SherbrookeSt. Joseph’s Healthcare HamiltonVancouver General HospitalHôpital Maisonneuve-RosemontLower Manhattan HospitalTexas Health DallasRegina General HospitalSt. Boniface HospitalAbbotsford Veterinary ClinicRoyal University HospitalSt. Paul's HospitalVitalité Health NetworkSt Joseph's Health CentreSt. Paul's HospitalRoyal Jubilee HospitalVictoria General HospitalJuravinski HospitalMcMaster University Medical Centre

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Sujets associés

SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesLong-Term Effects of COVID-19

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