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
Authors: Gaborit Benjamin , Vanhove Bernard , Lacombe Karine , Guimard Thomas , Hocqueloux Laurent , Perrier Ludivine , Dubee Vincent , Ferre Virginie , Bressollette Celine , Josien Régis , Thuaut Aurélie Le , Vibet Marie-Anne , Jobert Alexandra , Dailly Eric , Ader Florence , Brouard Sophie , Duvaux Odile , Raffi François ,   for the POLYCOR study group, Gaborit Benjamin , Raffi François , Lefebvre Maeva , Biron Charlotte , Lecomte Raphaël , Braudeau Cécile , Chauveau Marie , Dailly Eric , Deschanvres Colin , Gregoire Matthieu , Lecomte Anne-sophie , Flet Laurent , Tching-Sin Martine , Clapeau Eugenie , Orain Jérémie , Le Bras Morgane , Duval Alexandre , Portier Isabelle , Mora Clara , Boureau Anne-Sophie , Seronie-Doutriaux Etienne , Rouaud Agnès , Hublain Pamela , Le Jumeau De Kergaradec Laurence , Agasse Carole , Danielo Vivien , Bernard Megguy , Valero Régine , Lacombe Karine , Bollens Diane , Chiarabini Thibault , Valin Nadia , Ingiliz Patrick , Ouazene Zineb , Lefebvre Bénédicte , Lecardonnel François , Tran Christian , Feliho Raynald , Le Cam Manuela , Lamarque Julie , Lagneau Jean-Luc , Letaillandier Cyrielle , Daguenel-Nguyen Anne , Mayala-Kanda Clémentine , Fofana Djeneba , Fiorentino Arianna , Guimard Thomas , Bleher Yves , Esnault Jean-Luc , Merrien Dominique , Le Claire Blandine , Morrier Marine , Boucher Delphine , Lamberet Romain , Coudon Clémentine , Decours Romain , Durand Hélène , Pegeot Armelle , Migne Edwige , Pelerin Hélène , Poirier Yannick , Hocqueloux Laurent , Prazuck Thierry , De Dieuleveult Barbara , Plocco Pierre , Guinard Jérôme , Demonchy Elisa , Cua Eric , Devaud Edouard , Harent Stanislas , Parisey Marion , Lambert Céleste , Gobin Elise , Manson Julien , Pasquier Pierre , Martres Pascale , Kessedjian Patricia , Hitoto Hikombo , Crochette Nicolas , Perez-Grandiere Lucia , Laine Jean-Baptiste , Salmon-Rousseau Arnaud , Cosseron Guillaume , Blanchi Sophie , Ader Florence , Galvan Valérie , Moulin Alexia , Brochier Corinne , Oddone Julianne , Bouscambert-Duchamp Maude , Bani-Sadr Firouzé , N’guyen Yohan , Hentzien Maxime , Castex Cédric , Benoit Philippe , Brodard Véronique , Laureillard Didier , Sotto Albert , Loubet Paul , Martin Aurélie , Doncesco Régine , Mazet Julien , Soulairol Ian , Stephan Robin , Goehringer François , Thilly Nathalie , Prevot Michel , Jeulin Hélène , Talarmin Jean-Philippe , Khatchatourian Lydie , Saidan Nadia , Guerpillon Brice , Rameau Pascaline , Cassou Nicolas , Briand Thomas , Le Gall Florence , Le Breton Elodie , Joseph Cédric , Soriot-Thomas Sandrine , Andrejak Claire , Lanoix Jean-Philippe , Boddaert Sophie , Castelain Sandrine , Pestre Vincent , Woessner Juliette , Bayle Sophie , Branger Stéphanie , Christides Christine , Bielefeld Philippe , Lacroix Adèle , Pillard-Gagliano Roselyne , Trinh Isabelle , Lafitte Pierre , Giordano Guillermo , Finello Malena , Ledesma Ignacio , Martini Gustavo , Delafontaine Benjamin , Corus Iris , Baby Pierre , Catherinot Emilie , Goyard Céline , Chauveau Simon , Choucair Jad , D’urso Beatrice , Da Silva Costa Marie , Le Meur Lucie , Vasse Marc , Pascreau Tiffany , Farfour Eric , Dervieux Benjamin , Kaeuffer C Charlotte , Danion François , Hansmann Yves , Lefebvre Nicolas , Ruch Yvon , Ursenbach Axel , Schmidt-Mutter Catherine , Suliman Muhtadi , Hutt Anne , Becker Guillaume , Laugel Elodie , Bayer Sophie , Dubee Vincent , Mahieu Rafael , Daniel Valérie , Lefeuvre Caroline , Ducancelle Alexandra , Gagnard Jean-Charles , Mohebbi Abolfzl , Dehais Mélanie , Raccah Sophie , Pouliquen Anne-Lise , Klasen Alison , Forestier Emmanuel , Carret Marie-Christine , Liardot Severine , Grosjean Jérôme , Faucher Jean-François , Brisset Josselin , Cypierre Anne , Durox Hélène , Pinet Pauline , Ducroix-Roubertou Sophie , Genet Claire , Vallejo Christine , Hantz Sébastien , Gousseff Marie , Merlet Antoine , Bigot Sébastien , Girard De Courtilles Marion , Pouedras Pascal , Lariviere Delphine , Verdon Renaud , Dargere Sylvie , Michon Jocelyn , Fournier Anna , Brucato Sylvie , Gautier Séverine , Valentin Cécile , Ricci Anne , Alix Antoine , Lacassin-Beller Flore , Rousseau Sophie , Dimet Jérôme , Boivin Anne-Hélène , Larregle Maylis , Rousseau Guillaume , Assaf Ady , Vuotto Fanny , Faure Karine , Joachim Camille , Bocket Laurence , Diallo Kévin , Saffore Jessy , Madeline Isabelle , Chabanon Pauline , Allou Nathalie , Fernandes Elisabeth , Gruliere Anne-Sophie , Botelho-Nevers Elisabeth , Gagneux-Brunon Amandine , Ronat Véronique , Casimir Nadine , Pillet Sylvie , Bertholon Frédérique , Pialloux Gilles , Bachir Elrufaai Marwa , Calin Ruxandra , Thibaut Pélagie , Tendjaoui Fatima , Fillon Julie , Morand-Joubert Laurence , Vareil Marc-Olivier , Wille Heidi , Menager Philippe , Cordel Hugues , Mohammed-Kassim Youssouf , Rathouin Vanessa , Brichler Ségolène , Cabie André , Lehoux Mélanie , Guitteaud Karine , Sylla Karamba , Bigeard Bastien , Campana Valentine , Calmont Isabelle , Lamaignere Jean-Louis , Deppenweiller Marine , Padoin Christophe , Thilbault Marine , Fagour Laurence , Najioullah Fatiha , Komla-Soukha Isabelle , Roncato-Saberan Mariam , Martinot Martin , Mohseni Zadeh Mahsa , Gravier Simon , Ion Ciprian , Kayser Damien , Schieber Pachart Anne , Eyriey Magali , Henric Anaïs , Daniel Kaiser Jean , De Briel Dominique , Duvaux Odile , Evanno Gwenaëlle , Royer Pierre-Joseph , Rousse Juliette , Ciron Carine , Lhériteau Elsa , Rouvray Gaëtane , Mougeolle Alan , Rillet Auriane , Despons Sophie , Mevel Edwige , Shneiker Françoise , Josien Régis , Braudeau Cécile , Brouard Sophie , le Mai Hoa , Appau-Danquah Elise , Daniel Amélie , Grybek Virginie , Gueneau David , Gautier Marion , Martin-Gauthier Joëlle , Rebouilleau Emily , Herault Joseph , Roman Tanguy , Plantard Sorady , Chauveau Patrice , Chiffoleau Anne , Thauvin Stéphanie , Flet Laurent , Tching-Sin Martine , Clapeau Eugenie , Charreau Isabelle , Hoen Bruno , Solas-Chesneau Caroline , Vabret Astrid 
Published: October 2023

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 (&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.

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.