| Title: |
Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial |
| Authors: |
Ader, Florence; Bouscambert-Duchamp, Maude; Hites, Maya; Peiffer-Smadja, Nathan; Poissy, Julien; Belhadi, Drifa; Diallo, Alpha; Lê, Minh-Patrick; Peytavin, Gilles; Staub, Thérèse; Greil, Richard; Guedj, Jérémie; Paiva, Jose-Artur; Costagliola, Dominique; Yazdanpanah, Yazdan; Burdet, Charles; Mentré, France; Egle, Alexander; Joannidis, Michael; Lamprecht, Bernd; Altdorfer, Antoine; Belkhir, Leila; Fraipont, Vincent; Verschelden, Gil; Aboab, Jérôme; Ait-Oufella, Hafid; Andrejak, Claire; Andreu, Pascal; Argaud, Laurent; Bani-Sadr, Firouzé; Benezit, François; Blot, Mathieu; Botelho-Nevers, Elisabeth; Bouadma, Lila; Bouchaud, Olivier; Bougon, David; Bouiller, Kevin; Bounes-Vardon, Fanny; Boutoille, David; Boyer, Alexandre; Bruel, Cédric; Cabié, André; Canet, Emmanuel; Cazanave, Charles; Chabartier, Cyrille; Chirouze, Catherine; Clere-Jehl, Raphaël; Courjon, Johan; Crockett, Flora; Danion, François; Delbove, Agathe; Dellamonica, Jean; Djossou, Félix; Dubost, Clément; Duvignaud, Alexandre; Epaulard, Olivier; Epelboin, Loïc; Fartoukh, Murielle; Faure, Karine; Faure, Emmanuel; Ferry, Tristan; Ficko, Cécile; Figueiredo, Samy; Gaborit, Benjamin; Gaci, Rostane; Gagneux-Brunon, Amandine; Gallien, Sébastien; Garot, Denis; Geri, Guillaume; Gibot, Sébastien; Goehringer, François; Gousseff, Marie; Gruson, Didier; Hansmann, Yves; Hinschberger, Olivier; Jaureguiberry, Stéphane; Jeanmichel, Vanessa; Kerneis, Solen; Kimmoun, Antoine; Klouche, Kada; Lachâtre, Marie; Lacombe, Karine; Laine, Fabrice; Lanoix, Jean-Philippe; Launay, Odile; Laviolle, Bruno; Le Moing, Vincent; Le Pavec, Jérôme; Le Tulzo, Yves; Le Turnier, Paul; Lebeaux, David; Lefevre, Benjamin; Leroy, Sylvie; Lescure, François-Xavier; Lessire, Henry; Leveau, Benjamin; Loubet, Paul; Makinson, Alain; Malvy, Denis; Marquette, Charles-Hugo; Martin-Blondel, Guillaume; Martinot, Martin; Mayaux, Julien; Mekontso-Dessap, Armand; Meziani, Ferhat; Mira, Jean-Paul; Molina, Jean-Michel; Monnet, Xavier; Mootien, Joy; Mourvillier, Bruno; Murris-Espin, Marlène; Navellou, Jean-Christophe; Nseir, Saad; Oulehri, Walid; Perpoint, Thomas; Pialoux, Gilles; Pilmis, Benoît; Piriou, Vincent; Piroth, Lionel; Pourcher, Valérie; Quenot, Jean-Pierre; Raffi, François; Reignier, Jean; Revest, Matthieu; Richard, Jean-Christophe; Riu-Poulenc, Béatrice; Robert, Céline; Roger, Pierre-Alexandre; Roger, Claire; Rouveix-Nordon, Elisabeth; Ruch, Yvon; Saidani, Nadia; Sayre, Naomi; Senneville, Eric; Sotto, Albert; Stefan, Francois; Tacquard, Charles; Terzi, Nicolas; Textoris, Julien; Thiery, Guillaume; Timsit, Jean-François; Tolsma, Violaine; Turmel, Jean-Marie; Valour, Florent; Wallet, Florent; Wattecamps, Guilhem; Zerbib, Yoann; Berna, Marc; Reuter, Jean; Braz, Sandra; Ferreira Ribeiro, Joao-Miguel; Paiva, José-Artur; Roncon-Albuquerque, Roberto; Gaymard, Alexandre; Lina, Bruno; Tubiana, Sarah; Couffin-Cadièrgues, Sandrine; Esperou, Hélène; Dechanet, Aline; Delmas, Christelle; Fougerou, Claire; Mercier, Noémie; Noret, Marion; Saillard, Juliette; Velou, Priyanka |
| Contributors: |
Hospices Civils de Lyon (HCL); Centre International de Recherche en Infectiologie (CIRI); École normale supérieure de Lyon (ENS de Lyon); Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Université libre de Bruxelles = Free University of Brussels (ULB); Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord; Imperial College London; Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF); Université de Lille-Centre National de la Recherche Scientifique (CNRS); ANRS - Maladies infectieuses émergentes (ANRS - MIE); Institut National de la Santé et de la Recherche Médicale (INSERM); Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S 1144 / U1144)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Centre Hospitalier de Luxembourg Luxembourg (CHL); Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU); Universidade do Porto = University of Porto; Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP); Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU); Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp); Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM); Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre d'Investigation Clinique Rennes (CIC); Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM); ARN bactériens et médecine (BRM); Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes (Biosit : Biologie - Santé - Innovation Technologique); Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon); Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Modeling & analysis for medical imaging and Diagnosis (MYRIAD); Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL); European Union Commission, French Ministry of Health, Domaine d'intérêt majeur One Health Île-de-France, REACTing, Fonds Erasme-COVID-Université Libre de Bruxelles, Belgian Health Care Knowledge Centre, Austrian Group Medical Tumor, European Regional Development Fund, Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation. |
| Source: |
ISSN: 1473-3099. |
| Publisher Information: |
CCSD; Elsevier Science; The Lancet Pub. Group, 2001- |
| Publication Year: |
2022 |
| Collection: |
Université Jean Monnet – Saint-Etienne: HAL |
| Subject Terms: |
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases |
| Description: |
International audience ; Background: The antiviral efficacy of remdesivir against SARS-CoV-2 is still controversial. We aimed to evaluate the clinical efficacy of remdesivir plus standard of care compared with standard of care alone in patients admitted to hospital with COVID-19, with indication of oxygen or ventilator support.Methods: DisCoVeRy was a phase 3, open-label, adaptive, multicentre, randomised, controlled trial conducted in 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation. Exclusion criteria included elevated liver enzymes, severe chronic kidney disease, any contraindication to one of the studied treatments or their use in the 29 days before random assignment, or use of ribavirin, as well as pregnancy or breastfeeding. Participants were randomly assigned (1:1:1:1:1) to receive standard of care alone or in combination with remdesivir, lopinavir-ritonavir, lopinavir-ritonavir and interferon beta-1a, or hydroxychloroquine. Randomisation used computer-generated blocks of various sizes; it was stratified on severity of disease at inclusion and on European administrative region. Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged. The primary outcome was the clinical status at day 15 measured by the WHO seven-point ordinal scale, assessed in the intention-to-treat population. Safety was assessed in the modified intention-to-treat population and was one of the secondary outcomes. This trial is registered with the European Clinical Trials Database, EudraCT2020-000936-23, and ClinicalTrials.gov, NCT04315948.Findings: Between March 22, 2020, and Jan 21, 2021, 857 participants were ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/34534511; PUBMED: 34534511 |
| DOI: |
10.1016/S1473-3099(21)00485-0 |
| Availability: |
https://univ-rennes.hal.science/hal-03812289; https://univ-rennes.hal.science/hal-03812289v1/document; https://univ-rennes.hal.science/hal-03812289v1/file/Ader%20et%20al%20-%202021%20-%20Remdesivir%20plus%20standard%20of%20care%20versus%20standard.pdf; https://doi.org/10.1016/S1473-3099(21)00485-0 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.89FB39B4 |
| Database: |
BASE |