Accès ouvert déclaré
2023
article
Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial
Benjamin Gaborit, Bernard Vanhove, Karine Lacombe, Thomas Guimard, Laurent Hocqueloux, Ludivine Perrier, Vincent Dubée, Virginie Ferré, Céline Bressollette‐Bodin, Régis Josien, Aurélie Le Thuaut, Marie‐Anne Vibet, Alexandra Jobert, Éric Dailly, Florence Ader, Sophie Brouard, Odile Duvaux, François Raffi, M. Lefèbvre, Charlotte Biron, R. Lecomte, Cécile Braudeau, Marie Chauveau, Colin Deschanvres, Matthieu Grégoire, A Lecomte, Laurent Flet, Martine Tching-Sin, Eugenie Clapeau, Jéremie Orain, Morgane Le Bras, Alexandre Duval, Isabelle Portier, Anne‐Sophie Boureau, Etienne Seronie-Doutriaux, Agnès Rouaud, Pamela Hublain, Laurence Le Jumeau De Kergaradec, Carole Agasse, Vivien Danielo, Megguy Bernard, R. Valéro, Diane Bollens, Thibault Chiarabini, Nadia Valin, Patrick Ingiliz, Zineb Ouazene, Bénédicte Lefebvre, François Lecardonnel, Christian Tran, Raynald Feliho, Manuela Le Cam, Julie Lamarque, J. Lagneau, Cyrielle Letaillandier, Anne Daguenel-Nguyen, Clémentine Mayala-Kanda, Djeneba Fofana, Arianna Fiorentino, Yves Bleher, Jean-Luc Esnault, Dominique Merrien, Blandine Le Claire, Marine Morrier, Delphine Boucher, R. Lamberet, Clémentine Coudon, Romain Decours, Hélène Durand, Armelle Pegeot, Edwige Migne, Hélène Pelerin, Yannick Poirier, Thiérry Prazuck, Barbara De Dieuleveult, Pierre Plocco, Jérôme Guinard, Élisa Demonchy, Éric Cua, Edouard Devaud, Stanislas Harent, Marion Parisey, Céleste Lambert, E. Gobin, Julien Manson, Pierre Pasquier, Pascale Martres, Patricia Kessedjian, Hikombo Hitoto, N. Crochette, Lucia Perez-Grandiere, Jean-Baptiste Laine, Arnaud Salmon‐Rousseau, Guillaume Cosseron, Sophie Blanchi, Valérie Galvan, A. C. Simões Moulin, C. Brochier, Julianne Oddone, Maude Bouscambert‐Duchamp, Firouzé Bani‐Sadr, Yohan N’Guyen, Maxime Hentzien, Cédric Castex, P Benoit, Véronique Brodard, Didier Laureillard, Albert Sotto, Paul Loubet, Aurélie Martin, Régine Doncesco, Julien Mazet, Ian Soulairol, Robin Stéphan, François Goehringer, Nathalie Thilly, Michel Prevot, Hélène Jeulin, Jean‐Philippe Talarmin, L. Khatchatourian, Nadia Saidan, Brice Guerpillon, Pascaline Rameau, Nicolas Cassou, Thomas Briand, Florence Le Gall, Élodie Breton, Cédric Joseph, S. Soriot‐Thomas, Claire Andréjak, Jean‐Philippe Lanoix, Sophie Boddaert, Sandrine Castelain, Vincent Pestre, Juliette Woessner, S. Bayle, S. Branger, Christine Christides, Philippe Bielefeld, Adèle Lacroix, Roselyne Pillard-Gagliano, Isabelle Trinh, Pierre Lafitte, Guillermo Giordano, Malena Finello, Ignacio Ledesma, Gustavo Martini, Benjamin Delafontaine, Iris Corus, Pierre Baby, Émilie Catherinot, C. Goyard, Simon Chauveau, Jad Choucair, B. D'Urso, Marie Da Silva Costa, Lucie Le Meur, Marc Vasse, Tiffany Pascreau, Éric Farfour, Benjamin Dervieux, Charlotte Kaeuffer, François Danion, Yves Hansmann, Nicolas Lefèbvre, Yvon Ruch, Axel Ursenbach, Catherine Schmidt‐Mutter, Muhtadi Suliman, Anne Hutt, Guillaume Becker, Elodie Laugel, Sophie Bayer, Rafaël Mahieu, Valérie Daniel, Caroline Lefeuvre, Alexandra Ducancelle, Jean-Charles Gagnard, Abolfzl Mohebbi, Mélanie Dehais, Sophie Raccah, Anne-Lise Pouliquen, Alison Klasen, E. Forestier, Marie-Christine Carret, Severine Liardot, Jérôme Grosjean, Jean‐François Faucher, J M Brisset, A. Cypierre, H. Durox, P. Pinet, S. Ducroix-Roubertou, Claire Genet, Christine Vallejo, Sébastien Hantz, Marie Gousseff, Antoine Merlet, Sébastien Bigot, M Girard de Courtilles, P. Pouëdras, Delphine Larivière, Renaud Verdon, S. Dargère, Jocelyn Michon, Anna Fournier, Sylvie Brucato, Séverine Gautier, Cécile Valentin, Anne Ricci, Antoine Alix, Flore Lacassin-Beller, Sophie Rousseau, Jérôme Dimet, Anne-Hélène Boivin, Maylis Larregle, Guillaume Rousseau, Ady Assaf, Fanny Vuotto, Karine Faure, Camille Joachim, Laurence Bocket, K. Diallo, Jessy Saffore, Isabelle Madeline, Pauline Chabanon, Nathalie Allou, Elisabeth Fernandes, Anne-Sophie Gruliere, Élisabeth Botelho-Nevers, Amandine Gagneux‐Brunon, Véronique Ronat, Nadine Casimir, Sylvie Pillet, Frédérique Bertholon, G Pialloux, Marwa Bachir Elrufaai, Ruxandra Câlin, Pélagie Thibaut, Fatima Taibi Tendjaoui, Julie Fillon, Laurence Morand‐Joubert, Marc-Olivier Vareil, H. Wille, Philippe Menager, Hugues Cordel, Youssouf Mohammed-Kassim, Vanessa Rathouin, Ségolène Brichler, André Cabie, Mélanie Lehoux, K Guitteaud, Karamba Sylla, B Bigeard, Valentine Campana, Isabelle Calmont, Jean-Louis Lamaignère, Marine Deppenweiller, Christophe Padoin, Marine Thilbault, Laurence Fagour, Fatiha Najioullah, Isabelle Komla-Soukha, Mariam Roncato-Sabéran, M. Martinot, M. Mohseni Zadeh, Simon Gravier, Ciprian Ion, D. Kayser, Anne Pachart, Magali Eyriey, A Henric, Jean Daniel Kaiser, Dominique De Briel, Gwénaëlle Evanno, Pierre‐Joseph Royer, Juliette Rousse, Carine Ciron, Elsa Lhériteau, Gaëtane Rouvray, Alan Mougeolle, Auriane Rillet, Sophie Despons, Edwige Mevel, Françoise Shneiker, Hoa Le, Elise Appau-Danquah, Amélie Daniel, Virginie Grybek, David Gueneau, M Gautier, Joëlle Martin-Gauthier, Emily Rebouilleau, J P Hérault, Tanguy Roman, Sorady Plantard, Patrice Chauveau, Anne Chiffoleau, Stéphanie Thauvin, Isabelle Charreau, Bruno Hoen, Caroline Solas-Chesneau, Astrid Vabret
2Citations signalées — pas une note de qualité
19Institutions déclarées
1Pays d’affiliation déclarés
Résumé fourni par la source
Abstract Background We evaluated the safety and efficacy of XAV-19, an antispike glyco-humanized swine polyclonal neutralizing antibody in patients hospitalized with severe coronavirus disease 2019 (COVID-19). Methods This phase 2b clinical trial enrolled adult patients from 34 hospitals in France. Eligible patients had a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 within 14 days of onset of symptoms that required hospitalization for low-flow oxygen therapy (<6 L/min of oxygen). Patients were randomly assigned to receive a single intravenous infusion of 2 mg/kg of XAV-19 or placebo. The primary end point was the occurrence of death or severe respiratory failure between baseline and day 15. Results Between January 12, 2021, and April 16, 2021, 398 patients were enrolled in the study and randomly assigned to XAV-19 or placebo. The modified intention-to-treat population comprised 388 participants who received full perfusion of XAV-19 (199 patients) or placebo (189 patients). The mean (SD) age was 59.8 (12.4) years, 249 (64.2%) individuals were men, and the median time (interquartile range) from symptom onset to enrollment was 9 (7–10) days. There was no statistically significant decrease in the cumulative incidence of death or severe respiratory failure through day 15 in the XAV-19 group vs the placebo group (53/199 [26.6%] vs 48/189 [25.4%]; adjusted risk difference, 0.6%; 95% CI, −6% to 7%; hazard ratio, 1.03; 95% CI, 0.64–1.66; P = .90). In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29. Conclusions Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial
- Date Crossref
- 20/10/2023
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.
Institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Sujets associés
SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesImmune responses and vaccinations