Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19

Phase 2/3 Terminated 290 enrolled Xenothera SAS

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.

Timeline

Start: 2021-04-28
Primary completion: 2022-11-28
Completion: 2022-11-28

Outcome

Missed primary endpoint

Stopped (Enrollment): “Lack of recruitment”

paper Underpowered statistics did not allow the detection of any difference in the primary endpoint between the two groups or in stratified groups. PMID 38694503 ↗

Publications

Poulakou G, Royer PJ, Evgeniev N, Evanno G, Shneiker F, Marcelin AG, Vanhove B, Duvaux O, Marot S, Calvez V. Anti-SARS-CoV-2 glyco-humanized polyclonal antibody XAV-19: phase II/III randomized placebo-controlled trial shows acceleration to recovery for mild to moderate patients with COVID-19. Front Immunol. 2024 Apr 17;15:1330178. doi: 10.3389/fimmu.2024.1330178. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	XAV-19	Protein / enzyme biologic	150 mg	Intravenous