NCT04779879

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

A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Sotrovimab (Gen1)	Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
BIOLOGICAL	Sotrovimab (Gen2)	Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
BIOLOGICAL	Sotrovimab (Gen2)	Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-08-20
• Completion: 2022-04-06
• First posted: 2021-03-03
• Last updated: 2023-05-03
• Results posted: 2022-11-10

Locations

31 sites across 5 countries: United States, Canada, Italy, South Korea, Spain

Regulatory

• FDA-regulated drug study