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

Completed · Phase 2

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04779879

Run by

Vir Biotechnology, Inc.

People needed

354

Starts

2021-02-18

Expected to finish

2022-04-06

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Investigative Site — Anniston, Alabama, United States
• Investigative Site — Bakersfield, California, United States
• Investigative Site — Northridge, California, United States
• Investigative Site — Ft. Pierce, Florida, United States
• Investigative Site — Gainesville, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Orlando, Florida, United States
• Investigative Site — Pembroke Pines, Florida, United States
• Investigative Site — Tampa, Florida, United States
• Investigative Site — Columbus, Georgia, United States
• Investigative Site — Winfield, Illinois, United States
• Investigative Site — Rockville, Maryland, United States
• Investigative Site — The Bronx, New York, United States
• Investigative Site — Houston, Texas, United States
• Investigative Site — Sarnia, Ontario, Canada
• Investigative Site — Toronto, Ontario, Canada
• Investigative Site — Milan, Italy
• Investigative Site — Daejeon, South Korea
• Investigative Site — Alicante, Spain
• Investigative Site — Barcelona, Spain
• Investigative Site — Centelles, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.