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.
Biological: VIR-7831 (sotrovimab)
VIR-7831 (sotrovimab) given by intravenous infusion (single dose)
Drug: Placebo
Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)
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
Investigative Site
Anniston, Alabama, United States
Investigative Site
Cullman, Alabama, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Doral, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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North Miami, Florida, United States
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Palmetto Bay, Florida, United States
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Pembroke Pines, Florida, United States
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Pompano Beach, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Stockbridge, Georgia, United States
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Idaho Falls, Idaho, United States
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Mishawaka, Indiana, United States
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Lake Charles, Louisiana, United States
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Marrero, Louisiana, United States
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Baltimore, Maryland, United States
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Caro, Michigan, United States
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Hazelwood, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Santa Fe, New Mexico, United States
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Bronx, New York, United States
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Asheboro, North Carolina, United States
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Charlotte, North Carolina, United States
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Columbus, Ohio, United States
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Smithfield, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Austin, Texas, United States
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Baytown, Texas, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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El Paso, Texas, United States
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Forney, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Laredo, Texas, United States
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McAllen, Texas, United States
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Mesquite, Texas, United States
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Sugar Land, Texas, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Vienna, Austria
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Vienna, Austria
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Belo Horizonte, Minas Gerais, Brazil
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Maringá, Parana, Brazil
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Natal, Rio Grande Do Norte, Brazil
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Passo Fundo, Rio Grande Do Sul, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil
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Chapecó, Santa Catarina, Brazil
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Santo André, Sao Paulo, Brazil
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Vila Assuncao, Sao Paulo, Brazil
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Campinas, São Paulo, Brazil
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Bellavista, Callao, Peru
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El Agustino, Lima, Peru
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Huaral, Lima, Peru
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San Isidro, Lima, Peru
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Bella Vista, Peru
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Lima, Peru
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Centelles, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Albacete, Spain
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Girona, Spain
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Granada, Spain
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Vigo, Spain
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Belfast, United Kingdom