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Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

NCT04913675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1065

Last updated 2024-03-07

Study results available
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Summary

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression

Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Conditions

  • Covid19

Interventions

BIOLOGICAL

sotrovimab

Sotrovimab 500 mg given by intravenous infusion over 15 min

BIOLOGICAL

sotrovimab

Sotrovimab 500 mg given by intramuscular injection

BIOLOGICAL

sotrovimab

Sotrovimab 250 mg given by intramuscular injection

BIOLOGICAL

sotrovimab

Sotrovimab 2000 mg given by intravenous infusion over 60 min

BIOLOGICAL

Sotrovimab

Sotrovimab 2000 mg given by intravenous infusion over 30 min

BIOLOGICAL

Sotrovimab

Sotrovimab 2000 mg given by intravenous infusion over 15 min

BIOLOGICAL

Sotrovimab

Sotrovimab up to 3000 mg given by intravenous infusion over 90 min

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-07-19
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States
  • France
  • Ukraine

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 NCT04913675 on ClinicalTrials.gov