VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE)

Vir Biotechnology

Status and phase: Completed; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Biological: VIR-7831 (sotrovimab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04545060

GSK Study 214367 (Other Identifier)

VIR-7831-5001

Details and patient eligibility

About

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Enrollment: 1,057 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
• Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

Exclusion criteria

• Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
• Symptoms consistent with severe COVID-19
• Participants who, in the judgement of the investigator are likely to die in the next 7 days
• Severely immunocompromised participants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,057 participants in 2 patient groups, including a placebo group

VIR-7831 (Sotrovimab)

Experimental group

Description:

Participants received 500 mg sotrovimab administered intravenously (IV)

Treatment:

Biological: VIR-7831 (sotrovimab)

Placebo

Placebo Comparator group

Description:

Participants received placebo administered intravenously (IV)

Treatment:

Drug: Placebo