Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

Summary

This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

Timeline

Start

2021-02-18

Primary completion

2021-08-20

Completion

2022-04-06

Publications

• Gupta A, Perez-Rodriguez MT, Gonzalez-Rojas Y, Ramgopal M, Free A, Han J, Moore J, Givens N, Yates PJ, Walker JT, Connolly MB, Schnell G, Imber V, Anselm R, Winograd L, Segal S, Harrison S, Skingsley A, Aldinger M, Peppercorn A, Moya J. Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19: A Randomized Clinical Trial. Drugs R D. 2025 Dec;25(4):353-365. doi: 10.1007/s40268-025-00529-2. Epub 2025 Nov 24.
• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Drugs

Indications