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

NCT04779879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2023-05-03

Study results available
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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

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2021-08-20
Completion
2022-04-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04779879 on ClinicalTrials.gov