Efficacy and safety of anakinra in adults presenting deteriorating respiratory symptoms from COVID-19: a randomized controlled trial
2022
Audemard-Verger, Alexandra | Le Gouge, Amélie | Pestre, Vincent | Courjon, Johan | Langlois, Vincent | Vareil, Marc-Olivier | Devaux, Mathilde | Bienvenu, Boris | Leroy, Vincent | Goulabchand, Radjiv | Colombain, Léa | Bigot, Adrien | Guimard, Thomas | Douadi, Youcef | Urbanski, Geoffrey | Faucher, Jean-François | Maulin, Laurence | Lioger, Bertrand | Talarmin, Jean-Philippe | Groh, Matthieu | Emmerich, Joseph | Deriaz, Sophie | Ferreira-Maldent, Nicole | Cook, Ann-Rose | Lengellé, Céline | Bourgoin, Hélène | Mékinian, Arsène | Aouba, Achille | Maillot, François | Caille, Agnès | Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) | Université de Tours (UT) | Centre d’Investigation Clinique [Tours] CIC 1415 (CIC) ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Institut National de la Santé et de la Recherche Médicale (INSERM) | Centre Hospitalier Henri Duffaut (Avignon) | Service d'infectiologie [CHU Nice] ; Centre Hospitalier Universitaire de Nice (CHU Nice) | Groupe Hospitalier du Havre Hôpital Jacques Monod (MONTIVILLIERS) (GHH) | Centre Hospitalier de la Côte Basque (CHCB) | Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy] | Hôpital Saint-Joseph [Marseille] | Clinique Teissier (Valenciennes) (AHNAC) | Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) | Service des Maladies Infectieuses et Tropicales, Centre Hospitalier de Perpignan | Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée) | Centre hospitalier de Saint-Quentin | Centre Hospitalier Universitaire d'Angers (CHU Angers) ; PRES Université Nantes Angers Le Mans (UNAM) | Service des Maladies infectieuses et tropicales [CHU Limoges] ; CHU Limoges | Epidémiologie des Maladies Chroniques en zone tropicale (EpiMaCT) ; Institut de Recherche pour le Développement (IRD)-CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-OmégaHealth (ΩHealth) ; Université de Limoges (UNILIM)-Université de Limoges (UNILIM) | CH du Pays d'Aix, Aix-en-Provence | Centre Hospitalier de Blois (CHB) | CH de Quimper | Hôpital Foch [Suresnes] | Groupe Hospitalier Paris Saint-Joseph (hpsj) | Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques (CRESS (U1153 / UMR_A 1125)) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | Département de Pharmacologie [CHRU Tours] ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) | CHU Saint-Antoine [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) | CHU Caen ; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)
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Mostrar más [+] Menos [-]Inglés. Objective: we aimed to investigate whether anakinra, an interleukin-1receptor inhibitor, could improve outcome in moderate COVID-19 patients. Methods: in this controlled, open-label trial, we enrolled adults with COVID-19 requiring oxygen. We randomly assigned patients to receive intravenous anakinra plus optimized standard of care (oSOC) vs. oSOC alone. The primary outcome was treatment success at day 14 defined as patient alive and not requiring mechanical ventilation or extracorporeal membrane oxygenation.Results: between 27th April and 6th October 2020, we enrolled 71 patients (240 patients planned to been enrolled): 37 were assigned to the anakinra group and 34 to oSOC group. The study ended prematurely by recommendation of the data and safety monitoring board due to safety concerns. On day 14, the proportion of treatment success was significantly lower in the anakinra group 70% (n=26) vs. 91% (n=31) in the oSOC group: risk difference -21 percentage points (95% CI, -39 to -2), odds ratio 0.23 (95% CI, 0.06 to 0.91), p=0.027. After a 28-day follow-up, 9 patients in the anakinra group and 3 in the oSOC group had died. Overall survival at day 28 was 75% (95% CI, 62% to 91%) in the anakinra group versus 91% (95% CI, 82% to 100%) (p=0.06) in the oSOC group. Serious adverse events occurred in 19 (51%) patients in the anakinra group and 18 (53%) in the oSOC group (p=0·89).
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