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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; Gaborit, Benjamin; Raffi, François; Lefebvre, Maeva; Biron, Charlotte; Lecomte, Raphaël; Braudeau, Cécile; [...]

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

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  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: 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; Gaborit, Benjamin; Raffi, François; Lefebvre, Maeva; Biron, Charlotte; Lecomte, Raphaël; Braudeau, Cécile; [...]
  • Erschienen: Oxford University Press (OUP), 2023
  • Erschienen in: Open Forum Infectious Diseases
  • Sprache: Englisch
  • DOI: 10.1093/ofid/ofad525
  • ISSN: 2328-8957
  • Schlagwörter: Infectious Diseases ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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 (&amp;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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang