Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study

Author:

Gaborit Benjamin12ORCID,Dailly Eric3,Vanhove Bernard4,Josien Régis56,Lacombe Karine7,Dubee Vincent8,Ferre Virginie29,Brouard Sophie6,Ader Florence1011,Vibet Marie-Anne12,Le Thuaut Aurélie12,Danger Richard6,Flet Laurent13,Omnes Anne12,Berly Laetitia12,Chiffoleau Anne12,Jobert Alexandra12,Duvaux Odile4,Raffi François12

Affiliation:

1. Department of Infectious Disease, Nantes University Hospital, Nantes, France

2. INSERM CIC1413, Nantes University Hospital, Nantes, France

3. Clinical Pharmacology Department, CHU Nantes, Nantes, France

4. Xenothera, Nantes, France

5. Laboratoire d’Immunologie, CIMNA, CHU Nantes, Nantes, France

6. Centre de Recherche en Transplantation et Immunologie UMR 1064, INSERM, Université de Nantes, ITUN, CHU Nantes, Nantes, France

7. Institut Pierre Louis d’Epidémiologie et de Santé Publique, Sorbonne Université, INSERM, AP-HP, Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France

8. Service de Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire d’Angers, Angers, France

9. Virology Laboratory University Hospital, Nantes, France

10. Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, Ecole Normale Supérieure de Lyon, Université Lyon, Lyon, France

11. Département des Maladies Infectieuses et Tropicales, Hospices Civils de Lyon, Lyon, France

12. CHU Nantes, Sponsor Department, Nantes, France

13. CHU Nantes, Pharmacy Department, Nantes, France

Abstract

We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in coronavirus disease 2019 (COVID-19)-related moderate pneumonia. The objective was to evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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