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

Gaborit et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad525, POLYCOR, NCT04453384, Oct 2023

https://c19early.org/gaborit.html

RCT 398 hospitalized patients with severe COVID-19 requiring low-flow oxygen therapy showing no significant difference in death or respiratory failure through day 15 with XAV-19 (a swine glyco-humanized polyclonal neutralizing antibody) compared to placebo.

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risk of death, 89.9% higher, RR 1.90, p = 0.29, treatment 10 of 199 (5.0%), control 5 of 189 (2.6%), day 60.

risk of death, 5.0% lower, RR 0.95, p = 1.00, treatment 3 of 199 (1.5%), control 3 of 189 (1.6%), NNT 1254, day 15.

risk of mechanical ventilation, 105.8% higher, RR 2.06, p = 0.03, treatment 26 of 199 (13.1%), control 12 of 189 (6.3%), day 29.

risk of ICU admission, 5.0% higher, RR 1.05, p = 0.90, treatment 42 of 199 (21.1%), control 38 of 189 (20.1%), day 29.

risk of progression, 4.9% higher, RR 1.05, p = 0.82, treatment 53 of 199 (26.6%), control 48 of 189 (25.4%), death or respitatory failure.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Gaborit et al., 20 Oct 2023, Double Blind Randomized Controlled Trial, placebo-controlled, France, peer-reviewed, mean age 59.8, 18 authors, study period 12 January, 2021 - 16 April, 2021, average treatment delay 8.5 days, trial NCT04453384 (history) (POLYCOR). Contact: benjamin.gaborit@chunantes.fr, francois.raffi@chu-nantes.fr.

This Paper XAV-19 All

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

MD Benjamin Gaborit, Bernard Vanhove, Karine Lacombe, Thomas Guimard, Laurent Hocqueloux, Ludivine Perrier, Vincent Dubee, Virginie Ferre, Celine Bressollette, Régis Josien, Aurélie Le Thuaut, Marie-Anne Vibet, Alexandra Jobert, Eric Dailly, Florence Ader, Sophie Brouard, Odile Duvaux, MD François Raffi, MD Benjamin Gaborit, MD François Raffi, Maeva Lefebvre, Charlotte Biron, Raphaël Lecomte, Cécile Braudeau, Marie Chauveau, Eric Dailly, Colin Deschanvres, Matthieu Gregoire, Anne-Sophie Lecomte, Laurent Flet, Martine Tching-Sin, Eugenie Clapeau, Jérémie Orain, Morgane Le Bras, Alexandre Duval, Isabelle Portier, Clara Mora, Anne-Sophie Boureau, Etienne Seronie-Doutriaux, Agnès Rouaud, Pamela Hublain, Laurence Le Jumeau De Kergaradec, Carole Agasse, Vivien Danielo, Megguy Bernard, Régine Valero, Karine Lacombe, Diane Bollens, Thibault Chiarabini, Nadia Valin, Patrick Ingiliz, Zineb Ouazene, Bénédicte Lefebvre, François Lecardonnel, Christian Tran, Raynald Feliho, Manuela Le Cam, Julie Lamarque, Jean-Luc Lagneau, Cyrielle Letaillandier, Anne Daguenel-Nguyen, Clémentine Mayala-Kanda, Djeneba Fofana, Arianna Fiorentino, Thomas Guimard, Yves Bleher, Jean-Luc Esnault, Dominique Merrien, Blandine Le Claire, Marine Morrier, Delphine Boucher, Romain Lamberet, Clémentine Coudon, Romain Decours, Hélène Durand, Armelle Pegeot, Edwige Migne, Hélène Pelerin, Yannick Poirier, Laurent Hocqueloux, Thierry Prazuck, Barbara De Dieuleveult, Pierre Plocco, Jérôme Guinard, Elisa Demonchy, Eric Cua, Edouard Devaud, Stanislas Harent, Marion Parisey, Céleste Lambert, Elise Gobin, Julien Manson, Pierre Pasquier, Pascale Martres, Patricia Kessedjian, Hikombo Hitoto, Nicolas Crochette, Lucia Perez-Grandiere, Jean-Baptiste Laine, Arnaud Salmon-Rousseau, Guillaume Cosseron, Sophie Blanchi, Florence Ader, Valérie Galvan, Alexia Moulin, Corinne Brochier, Julianne Oddone, Maude Bouscambert-Duchamp, Firouzé Bani-Sadr, Yohan N’guyen, Maxime Hentzien, Cédric Castex, Philippe Benoit, Véronique Brodard, Didier Laureillard, Albert Sotto, Paul Loubet, Aurélie Martin, Régine Doncesco, Julien Mazet, Ian Soulairol, Robin Stephan, François Goehringer, Nathalie Thilly, Michel Prevot, Hélène Jeulin, Jean-Philippe Talarmin, Lydie Khatchatourian, Nadia Saidan, Brice Guerpillon, Pascaline Rameau, Nicolas Cassou, Thomas Briand, Florence Le Gall, Elodie Le Breton, Cédric Joseph, Sandrine Soriot-Thomas, Claire Andrejak, Jean-Philippe Lanoix, Sophie Boddaert, Sandrine Castelain, Vincent Pestre, Juliette Woessner, Sophie Bayle, Stéphanie 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, Emilie Catherinot, Céline Goyard, Simon Chauveau, Jad Choucair, Beatrice D’urso, Marie Da Silva Costa, Lucie Le Meur, Marc Vasse, Tiffany Pascreau, Eric Farfour, Benjamin Dervieux, C Charlotte Kaeuffer, François Danion, Yves Hansmann, Nicolas Lefebvre, Yvon Ruch, Axel Ursenbach, Catherine Schmidt-Mutter, Muhtadi Suliman, Anne Hutt, Guillaume Becker, Elodie Laugel, Sophie Bayer, Vincent Dubee, Rafael Mahieu, Valérie Daniel, Caroline Lefeuvre, Alexandra Ducancelle, Jean-Charles Gagnard, Abolfzl Mohebbi, Mélanie Dehais, Sophie Raccah, Anne-Lise Pouliquen, Alison Klasen, Emmanuel Forestier, Marie-Christine Carret, Severine Liardot, Jérôme Grosjean, Jean-François Faucher, Josselin Brisset, Anne Cypierre, Hélène Durox, Pauline Pinet, Sophie Ducroix-Roubertou, Claire Genet, Christine Vallejo, Sébastien Hantz, Marie Gousseff, Antoine Merlet, Sébastien Bigot, Marion Girard De Courtilles, Pascal Pouedras, Delphine Lariviere, Renaud Verdon, Sylvie Dargere, 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, Kévin Diallo, Jessy Saffore, Isabelle Madeline, Pauline Chabanon, Nathalie Allou, Elisabeth Fernandes, Anne-Sophie Gruliere, Elisabeth Botelho-Nevers, Amandine Gagneux-Brunon, Véronique Ronat, Nadine Casimir, Sylvie Pillet, Frédérique Bertholon, Gilles Pialloux, Marwa Bachir Elrufaai, Ruxandra Calin, Pélagie Thibaut, Fatima Tendjaoui, Julie Fillon

Open Forum Infectious Diseases, doi:10.1093/ofid/ofad525

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 . 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.

Supplementary Data Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Notes Acknowledgments. The POLYCOR trial was supported by the Comité ad hoc de Pilotage National des Essais Thérapeutiques et Autres Recherches sur le COVID-19 (CAPNET, label Priorité Nationale de Recherche-National Research Priority). We thank the Biological Resource Centre for Biobanking (CHU Nantes, Nantes Université, Centre de Resources Biologiques [BB-0033_00040], Nantes, France). We thank the clinical and research teams as well as the pharmacists and virologists at all the participating clinical centers who contributed to the management of the study patients for their commitment to providing optimal patient care. Financial support. The POLYCOR study was funded and fully supported by the University Hospital of Nantes with support from the Bpifrance (Banque Publique d'Investissement) (BPI France) in the framework of the Investment for the Future Program (Programme d'Investissements d'Avenir) and Xenothera. Role of the funder/sponsor. Nantes University Hospital Research Department was the sponsor of the study. The funders of the study had no role in study conduct, data collection, or data analysis. Nantes University Hospital, BPI France, and..

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DOI record: { "DOI": "10.1093/ofid/ofad525", "ISSN": [ "2328-8957" ], "URL": "http://dx.doi.org/10.1093/ofid/ofad525", "abstract": "Abstract\n \n Background\n 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).\n \n \n Methods\n 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 (&lt;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.\n \n \n Results\n 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). 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Late treatment
is less effective

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