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Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial

dc.rights.licenseopenen_US
dc.contributor.authorLACOMBE, Karine
dc.contributor.authorHUESO, Thomas
dc.contributor.authorPORCHER, Raphael
dc.contributor.authorMEKINIAN, Arsene
dc.contributor.authorCHIARABINI, Thibault
dc.contributor.authorGEORGIN-LAVIALLE, Sophie
dc.contributor.authorADER, Florence
dc.contributor.authorSAISON, Julien
dc.contributor.authorMARTIN-BLONDEL, Guillaume
dc.contributor.authorDE CASTRO, Nathalie
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
dc.contributor.authorCAZANAVE, Charles
dc.contributor.authorFRANCOIS, Anne
dc.contributor.authorMOREL, Pascal
dc.contributor.authorHERMINE, Olivier
dc.contributor.authorPOURCHER, Valerie
dc.contributor.authorMICHEL, Marc
dc.contributor.authorLESCURE, Xavier
dc.contributor.authorSOUSSI, Nora
dc.contributor.authorBRUN, Phillipe
dc.contributor.authorPOMMERET, Fanny
dc.contributor.authorSELLIER, Pierre
dc.contributor.authorROUSSET, Stella
dc.contributor.authorPIROTH, Lionel
dc.contributor.authorMICHOT, Jean-Marie
dc.contributor.authorBARON, Gabriel
dc.contributor.authorDE LAMBALLERIE, Xavier
dc.contributor.authorMARIETTE, Xavier
dc.contributor.authorTHARAUX, Pierre-Louis
dc.contributor.authorRESCHE-RIGON, Matthieu
dc.contributor.authorRAVAUD, Philippe
dc.contributor.authorSIMON, Tabassome
dc.contributor.authorTIBERGHIEN, Pierre
dc.date.accessioned2023-12-11T10:43:32Z
dc.date.available2023-12-11T10:43:32Z
dc.date.issued2023-10-27
dc.identifier.issn2754-0413en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/186543
dc.description.abstractEnOBJECTIVE: To evaluate the efficacy of covid-19 convalescent plasma to treat patients admitted to hospital for moderate covid-19 disease with or without underlying immunodeficiency (CORIPLASM trial). DESIGN: Open label, randomised clinical trial. SETTING: CORIMUNO-19 cohort (publicly supported platform of open label, randomised controlled trials of immune modulatory drugs in patients admitted to hospital with moderate or severe covid-19 disease) based on 19 university and general hospitals across France, from 16 April 2020 to 21 April 2021. PARTICIPANTS: 120 adults (n=60 in the covid-19 convalescent plasma group, n=60 in the usual care group) admitted to hospital with a positive SARS-CoV2 test result, duration of symptoms <9 days, and World Health Organization score of 4 or 5. 49 patients (n=22, n=27) had underlying immunosuppression. INTERVENTIONS: Open label randomisation to usual care or four units (200-220 mL/unit, 2 units/day over two consecutive days) of covid-19 convalescent plasma with a seroneutralisation titre >40. MAIN OUTCOME MEASURES: Primary outcomes were proportion of patients with a WHO Clinical Progression Scale score of ≥6 on the 10 point scale on day 4 (higher values indicate a worse outcome), and survival without assisted ventilation or additional immunomodulatory treatment by day 14. Secondary outcomes were changes in WHO Clinical Progression Scale scores, overall survival, time to discharge, and time to end of dependence on oxygen supply. Predefined subgroups analyses included immunosuppression status, duration of symptoms before randomisation, and use of steroids. RESULTS: 120 patients were recruited and assigned to covid-19 convalescent plasma (n=60) or usual care (n=60), including 22 (covid-19 convalescent plasma) and 27 (usual care) patients who were immunocompromised. 13 (22%) patients who received convalescent plasma had a WHO Clinical Progression Scale score of ≥6 at day 4 versus eight (13%) patients who received usual care (adjusted odds ratio 1.88, 95% credible interval 0.71 to 5.24). By day 14, 19 (31.6%) patients in the convalescent plasma group and 20 (33.3%) patients in the usual care group needed ventilation, additional immunomodulatory treatment, or had died. For cumulative incidence of death, three (5%) patients in the convalescent plasma group and eight (13%) in the usual care group died by day 14 (adjusted hazard ratio 0.40, 95% confidence interval 0.10 to 1.53), and seven (12%) patients in the convalescent plasma group and 12 (20%) in the usual care group by day 28 (adjusted hazard ratio 0.51, 0.20 to 1.32). In a subgroup analysis performed in patients who were immunocompromised, transfusion of covid-19 convalescent plasma was associated with mortality (hazard ratio 0.39, 95% confidence interval 0.14 to 1.10). CONCLUSIONS: In this study, covid-19 convalescent plasma did not improve early outcomes in patients with moderate covid-19 disease. The efficacy of convalescent plasma in patients who are immunocompromised should be investigated further. TRIAL REGISTRATION: ClinicalTrials.gov NCT04345991.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/us/*
dc.subject.enCOVID-19
dc.subject.enBlood transfusion
dc.subject.enClinical trial
dc.title.enUse of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial
dc.title.alternativeBMJ Meden_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmjmed-2022-000427en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37920150en_US
bordeaux.journalBmj Medicineen_US
bordeaux.pagee000427en_US
bordeaux.volume2en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGIGHS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
bordeaux.identifier.funderIDMinistère de la Santéen_US
bordeaux.identifier.funderIDFondation pour la Recherche Médicaleen_US
hal.identifierhal-04335160
hal.version1
hal.date.transferred2023-12-11T10:43:36Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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