Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial.

Autor: Hites M; Clinic of Infectious Diseases, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles, Brussels, Belgium. Electronic address: Maya.Hites@hubruxelles.be., Massonnaud CR; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Lapique EL; Clinic of Infectious Diseases, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles, Brussels, Belgium., Belhadi D; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Jamard S; Service de Maladies Infectieuses Et Tropicales (SMIT), Centre Hospitalier Universitaire de Tours, 37044 Tours, France., Goehringer F; Université de Lorraine, CHRU de Nancy, Service des Maladies Infectieuses et Tropicales, F-54000 Nancy, France., Danion F; Hôpitaux Universitaires de Strasbourg, Département de maladies infectieuses et tropicales, F-67091 Strasbourg, France., Reignier J; CHU de Nantes, Service de Médecine Intensive et Réanimation, Université de Nantes, F-44093 Nantes, France., de Castro N; Département des Maladies Infectieuses et Tropicales, GH Saint-Louis/Lariboisière-Fernand Widal, Université de Paris Cité, INSERM U 944, Paris, France., Garot D; CHRU Tours, Service de Médecine Intensive Réanimation, F-37044 Tours, France., Lacombe K; Sorbonne Université, Inserm, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, F-75013 Paris, France; APHP, Hôpital Saint-Antoine, Service de maladies infectieuses et tropicales, F-75012 Paris, France., Tolsma V; Centre Hospitalier Annecy Genevois, Service des Maladies Infectieuses et Tropicales, F-74374 Annecy, France., Faure E; Université de Lille, CNRS, Inserm, CHU Lille, Institut Pasteur de Lille, U1019 - UMR 9017 - CIIL - Center for Infection and Immunity of Lille, F-59000 Lille, France., Malvy D; Department of Infectious Diseases and Tropical Medicine, CHU Bordeaux, Bordeaux, France., Staub T; Centre hospitalier de Luxembourg, Service des maladies infectieuses, L-1210 Luxembourg, Luxembourg., Courjon J; Université Côte d'Azur, CHU Nice, Nice, France, Infectious Disease Unit, Nice, France., Cazenave-Roblot F; Département des Maladies Infectieuses et Tropicales, CHU de Poitiers, INSERM U1070, Poitiers, France., Dyrhol Riise AM; Department of Infectious Diseases, Oslo University Hospital, 0424 Oslo, Norway., Leturnier P; Department of Infectious Diseases, Hôtel-Dieu University Hospital, University Hospital of Nantes, Nantes, France., Martin-Blondel G; CHU de Toulouse, Service des maladies infectieuses et Tropicales, F-31320 Toulouse, France; Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity) INSERM UMR1291 - CNRS UMR5051 - Université Toulouse III, F-31320 Toulouse, France., Roger C; Department of Anesthesiology, Critical Care Pain, and Emergency Medicine, Nimes University Hospital, Nimes, France., Akinosoglou K; Department of Internal Medicine and Infectious Diseases, University General Hospital of Patras, Patras, Greece., Moing VL; CHU de Montpellier, Service des Maladies Infectieuses et Tropicales, F-34295 Montpellier, France., Piroth L; CHU de Dijon, Département de Maladies Infectieuses, F-21000, Dijon, France; Université Bourgogne Franche-Comté, CIC 1432, INSERM, F-21000, Dijon, France., Sellier P; Infectious Diseases Department, Lariboisière Hospital, AP-HP, Paris, France., Lescure X; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Service de Maladies Infectieuses et Tropicales, F-75018 Paris, France., Trøseid M; Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway., Clevenbergh P; Infectious Diseases Clinic, CHU Brugmann, ULB, Brussels, Belgium., Dalgard O; Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway; Institute for Clinical Medicine, University of Oslo, Oslo, Norway., Gallien S; APHP, Hôpital Henri Mondor, Département de maladies infectieuses, F-94000 Créteil, France; INSERM U955, Team 16, IMRB Créteil, Créteil, France., Gousseff M; Maladies infectieuses, Centre Hospitalier Bretagne-Atlantique, Vannes, France., Loubet P; Infectious and Tropical Diseases Department, Nimes University Hospital, Nimes, France; VBIC, INSERM U1047, University of Montpellier, Nimes, France., Vardon-Bounes F; CHU de Toulouse, Département d'anesthésie et de soins intensifs, F-31300 Toulouse, France; Université Toulouse 3 Paul Sabatier, Inserm U1297, F-31300 Toulouse, France., Visée C; Department of Infectious Disease, Centre Hospitalier Régional Mons-Hainaut/Groupe Jolimont, Mons Belgium/Groupe Helora, Mons, Belgium., Belkhir L; Department of Internal Medicine and Infectious Diseases, Cliniques universitaires Saint-Luc, Brussels, Belgium., Botelho-Nevers É; CHU de Saint-Etienne, Service d'Infectiologie, F-42055 Saint-Etienne, France; Université Jean Monnet, Université Claude Bernard Lyon 1, GIMAP, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-42023 Saint-Etienne, France; CIC 1408, INSERM, F, 42055 Saint-Etienne, France., Cabié A; PCCEI, Univ Montpellier, Univ Antilles, Inserm, EFS, F-34394 Montpellier, France; CHU de Martinique, Service des maladies infectieuses et tropicales, Inserm CIC1424, F-97200 Fort de France, France., Kotanidou A; First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens Medical School, 45-47 Ipsilantou Street, 10676 Athens, Greece., Lanternier F; Infectious Diseases Unit, Necker-Enfants Malades University Hospital, AP-HP, Paris, France., Rouveix-Nordon E; AP-HP, Hôpital Ambroise-Paré, Service de Maladies Infectieuses et Tropicales, Boulogne-Billancourt, France., Silva S; EPIUnit - Instituto de Saúde Pública, Universidade do Porto, Rua das Taipas, no 135, 4050-600 Porto, Portugal., Thiery G; CHU Saint-Etienne, Hopital Nord, Medical Intensive Care Unit, Saint-Priest-En-Jarez, France., Poignard P; Groupe de Recherche en Infectiologie Clinique CIC-1406, Inserm - CHUGA - Université Grenoble Alpes, Grenoble, France; Univ. Grenoble Alpes, CEA, CNRS, Institut de Biologie Structurale (IBS), Grenoble, France; Laboratoire de Virologie, Center Hospitalier Universitaire Grenoble-Alpes, Grenoble, France., Carcelain G; Immunology Department, Robert Debré Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université Paris Cité, INSERM U976, Paris, France., Diallo A; ANRS | Maladies Infectieuses Emergentes, Paris, France., Mercier N; ANRS | Maladies Infectieuses Emergentes, Paris, France., Terzic V; ANRS | Maladies Infectieuses Emergentes, Paris, France., Bouscambert-Duchamp M; Hospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des virus respiratoires France Sud, F-69317 Lyon, France; Université Claude Bernard Lyon 1, Virpath, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372 Lyon, France., Gaymard A; Hospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des virus respiratoires France Sud, F-69317 Lyon, France; Université Claude Bernard Lyon 1, Virpath, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372 Lyon, France., Trabaud MA; Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France., Destras G; Hospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des virus respiratoires France Sud, F-69317 Lyon, France., Josset L; Hospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des virus respiratoires France Sud, F-69317 Lyon, France., Billard N; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Han TH; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Guedj J; Université Paris Cité, Inserm, IAME, F-75018 Paris, France., Couffin-Cadiergues S; Institut de santé publique, Pôle recherche clinique, INSERM, Paris, France., Dechanet A; AP-HP, Hôpital Bichat, Unité de recherche clinique, F-75018 Paris, France., Delmas C; Institut de santé publique, Pôle recherche clinique, INSERM, Paris, France., Esperou H; Institut de santé publique, Pôle recherche clinique, INSERM, Paris, France., Fougerou-Leurent C; CHU de Rennes, Université Rennes 1, Inserm CIC 1414, F-35000 Rennes, France., Mestre SL; ANRS | Maladies Infectieuses Emergentes, Paris, France., Métois A; AP-HP, Hôpital Bichat, Unité de recherche clinique, F-75018 Paris, France., Noret M; Renarci, Réseau National De Recherche Clinique En Infectiologie, Paris, France., Bally I; Univ. Grenoble Alpes, CEA, CNRS, Institut de Biologie Structurale (IBS), Grenoble, France., Dergan-Dylon S; Univ. Grenoble Alpes, CEA, CNRS, Institut de Biologie Structurale (IBS), Grenoble, France., Tubiana S; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Centre de ressources biologiques, F-75018 Paris, France., Kalif O; AP-HP, Hôpital Bichat, Centre de ressources biologiques, F-75018 Paris, France., Bergaud N; Hospices Civils de Lyon, Lyon, France., Leveau B; Hospices Civils de Lyon, Lyon, France., Eustace J; University College Cork, Cork, Ireland., Greil R; Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Paracelsus Medical University Salzburg, 5020 Salzburg, Austria; Cancer Cluster Salzburg, 5020 Salzburg, Austria; AGMT, 5020 Salzburg, Austria., Hajdu E; Department of Internal Medicine Infectiology Unit, Albert Szent-Györgyi Health Centre, University of Szeged, Állomás Street 1-3, 6725 Szeged, Hungary., Halanova M; LF UPJŠ - Pavol Jozef Šafárik University in Košice Faculty of Medicine, Košice, Slovakia., Paiva JA; Centro Hospitalar São João, Emergency and Intensive Care Department, Porto, Portugal; Universidade do Porto, Faculty of Medicine, Porto, Portugal., Piekarska A; Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź, Poland., Rodriguez Baño J; Infectious Diseases and Microbiology Division, Hospital Universitario Virgen Macarena, Sevilla, Spain., Tonby K; Department of Infectious Diseases, Oslo University Hospital, 0424 Oslo, Norway., Trojánek M; Department of Infectious Diseases, University Hospital Bulovka, Budínova 2, 180 81, Prague, Czech Republic., Tsiodras S; Fourth Department of Internal Medicine, Attikon University Hospital, Athens Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece., Unal S; Department of Infectious Diseases, Hacettepe University Faculty of Medicine, Ankara, Turkey., Burdet C; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Costagliola D; Sorbonne Université, Inserm, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, F-75013 Paris, France., Yazdanpanah Y; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Service de Maladies Infectieuses et Tropicales, F-75018 Paris, France., Peiffer-Smadja N; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Service de Maladies Infectieuses et Tropicales, F-75018 Paris, France; National Institute for Health Research, Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College London, London, UK., Mentré F; Université Paris Cité, Inserm, IAME, F-75018 Paris, France; AP-HP, Hôpital Bichat, Département d'Épidémiologie, Biostatistique et Recherche Clinique, F-75018 Paris, France., Ader F; Hospices Civils de Lyon, Hôpital de la Croix-Rousse, Département des Maladies Infectieuses et Tropicales, F-69004 Lyon, France; Université Claude Bernard Lyon 1, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372 Lyon, France.
Jazyk: angličtina
Zdroj: The Journal of infection [J Infect] 2024 Mar; Vol. 88 (3), pp. 106120. Date of Electronic Publication: 2024 Feb 16.
DOI: 10.1016/j.jinf.2024.106120
Abstrakt: Competing Interests: Declaration of Competing Interest M.H. reports grants from The Belgian Center for Knowledge (KCE), the Fonds Erasme-COVID-Université Libre de Bruxelles and the EU-Horizon program, for the submitted work; and has received support for attending meetings from Pfizer; support for participation on an advisory board for therapeutics on COVID-19; and support for leadership for the Belgian guidelines on therapeutics for COVID-19 and acting as a treasurer for the Belgian Society of Clinical Microbiology and Infectious Diseases. R.G. reports consulting fees from Celgene, Novartis, Roche, Bristol Myers Squibb, Takeda, Abbvie, AstraZeneca, Janssen, Merck Sharp & Dohme, Merck, Gilead, and Daiichi Sankvo; lecture fees from Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Sandoz, Abbvie, Gilead, and Daiichi Sankvo; support for attending meetings from Roche, Amgen, Janssen, AstraZeneca, Novartis, Merck Sharp & Dohme, Celgene, Gilead, Bristol Myers Squibb, Abbvie, and Daiichi Sankvo; participation in a Data Safety and Monitoring Board for Celgene, Novartis, Roche, Bristol Myers Squibb, Takeda, Abbvie, AstraZeneca, Janssen, Merck Sharp & Dohme, Merck, Gilead, and Daiichi Sankyo; research grants from Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Sandoz, Abbvie, Gilead, and Daiichi Sankyo. J.-A.P. reports consulting fees from Pfizer, Merck Sharp & Dohme, and Janssen-Cilag; lecture fees from Pfizer; and support for attending meetings from Pfizer. D.C. reports grants and lecture fees from Janssen and lecture fees from Gilead, outside the submitted work. C.B. reports participation in a Data Safety and Monitoring Board for 4Living Biotech; and consulting fees from Da Volterra and Mylan Pharmaceuticals, outside the submitted work. F.M. reports grants and consulting fees from Da Volterra, grants from Sanofi, and consulting fees from Ipsen, outside the submitted work. All other authors declare no competing interests.
Databáze: MEDLINE