Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 69 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Part A is double-blinded. Parts B and C are open label.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Sotrovimab (Gen1)
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
  • 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
Active Comparator
Sotrovimab (Gen2)
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
  • Biological: Sotrovimab (Gen2)
    Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

Recruiting Locations

More Details

NCT ID
NCT04779879
Status
Completed
Sponsor
Vir Biotechnology, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.