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

Vir Biotechnology

Status and phase: Completed; Phase 2

Conditions: Covid19

Treatments: Biological: Sotrovimab (Gen1); Biological: Sotrovimab (Gen2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04779879

GSK Study 216912 (Other Identifier)

VIR-7831-5006

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
• For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
• Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 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
• For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
• For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
• For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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354 participants in 2 patient groups

Sotrovimab (Gen1)

Active Comparator group

Description:

Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material

Treatment:

Biological: Sotrovimab (Gen2)

Biological: Sotrovimab (Gen2)

Biological: Sotrovimab (Gen1)

Sotrovimab (Gen2)

Active Comparator group

Description:

Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection

Treatment:

Biological: Sotrovimab (Gen2)

Biological: Sotrovimab (Gen2)