CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 354 enrolled
Drug / intervention
Sotrovimab (Gen1) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04779879
NCT04779879Phase 2Completed
CompareCT.gov

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)

Vir Biotechnology, Inc.·interventional·Posted Mar 3, 2021·Updated May 3, 2023

In Brief

A Phase 2 clinical trial evaluating Sotrovimab (Gen1) and Sotrovimab (Gen2) for Covid19. Completed, enrolled 354 participants across 31 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesCanada, Italy, South Korea, Spain, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 3, 2021
Enrollment StartFeb 18, 2021
Primary CompletionAug 20, 2021
Study CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.3 years ago

Interventions

Sotrovimab (Gen1)biological

Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material

Sotrovimab (Gen2)biological

Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

Sotrovimab (Gen2)biological

Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion