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
- Type de publi. : Article dans une revue
- Date de publi. : 27/10/2023
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Auteurs :
Karine LacombeThomas HuesoRaphaël PorcherArsène MékinianThibault ChiarabiniSophie Georgin-LavialleFlorence AderJulien SaisonGuillaume Martin-BlondelNathalie de CastroFabrice BonnetCharles CazanaveAnne FrancoisPascal MorelOlivier HermineValérie PourcherMarc MichelXavier LescureNora SoussiPhillipe BrunFanny PommeretPierre SellierStella RoussetLionel PirothJean-Marie MichotGabriel BaronXavier de LamballerieXavier MariettePierre-Louis TharauxMatthieu Resche-RigonPhilippe RavaudTabassome SimonPierre Tiberghien
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Organismes :
Institut Pierre Louis d'Epidémiologie et de Santé Publique
CHU Saint-Antoine [AP-HP]
Service d'hématologie clinique [Avicenne]
AP-HP - Hôpitaux Universitaires Paris Seine-Saint-Denis
Methods of therapeutic evaluation of chronic diseases | Méthodes de l’évaluation thérapeutique des maladies chroniques
Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques
Centre d'épidémiologie Clinique [Hôtel-Dieu]
CHU Saint-Antoine [AP-HP]
CHU Saint-Antoine [AP-HP]
CHU Tenon [AP-HP]
Centre International de Recherche en Infectiologie
Hospices Civils de Lyon
Centre hospitalier de Valence
Institut Toulousain des Maladies Infectieuses et Inflammatoires
Service Maladies infectieuses et tropicales [CHU Toulouse]
Service de maladies infectieuses et tropicales [Saint-Louis]
Bordeaux population health
Hôpital Saint-André
Service des Maladies Infectieuses et Tropicales A [Bordeaux]
Université de Bordeaux
Etablissement Français du Sang [La Plaine Saint-Denis]
Etablissement Français du Sang [La Plaine Saint-Denis]
Université Paris Cité
Service d'immuno-hématologie pédiatrique [CHU Necker]
Institut Pierre Louis d'Epidémiologie et de Santé Publique
CHU Pitié-Salpêtrière [AP-HP]
Université Paris-Est Créteil Val-de-Marne - Paris 12
Hôpital Henri Mondor
Université Paris-Est Créteil Val-de-Marne - Faculté de médecine
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
CHU Saint-Antoine [AP-HP]
Centre hospitalier de Valence
Institut Gustave Roussy
Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]
Service Maladies infectieuses et tropicales [CHU Toulouse]
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
Département d’Innovation Thérapeutique et essais précoces [Gustave Roussy]
Département de médecine oncologique [Gustave Roussy]
Methods of therapeutic evaluation of chronic diseases | Méthodes de l’évaluation thérapeutique des maladies chroniques
Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques
Centre d'épidémiologie Clinique [Hôtel-Dieu]
Unité des Virus Emergents
Centre de recherche en Immunologie des Infections virales et des maladies auto-immunes
Service de Rhumatologie [CHU Bicêtre]
Paris-Centre de Recherche Cardiovasculaire
Service de biostatistique et information médicale de l’hôpital Saint Louis (Equipe ECSTRA)
Institut de Myologie
Service de biostatistique et information médicale de l’hôpital Saint Louis (Equipe ECSTRA)
Institut de Myologie
CHU Saint-Antoine [AP-HP]
Etablissement Français du Sang [La Plaine Saint-Denis]
Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
- Publié dans BMJ Medicine le 06/04/2023
Résumé : Objective: 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.
Fichiers liés :
BPH_BMJMed_2023_Lacombe.pdf
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