Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
NCT ID: NCT04913675
Last Updated: 2024-03-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1065 participants
INTERVENTIONAL
2021-06-10
2023-03-24
Brief Summary
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Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Main Study - Sotrovimab 500 mg IV
sotrovimab
Sotrovimab 500 mg given by intravenous infusion over 15 min
Main Study - Sotrovimab 500 mg IM
sotrovimab
Sotrovimab 500 mg given by intramuscular injection
Main Study - Sotrovimab 250 mg IM
sotrovimab
Sotrovimab 250 mg given by intramuscular injection
Substudy (Cohort A) - Sotrovimab 2000 mg IV
sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 60 min
Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV
Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 30 min
Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV
Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 15 min
Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV
Sotrovimab
Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Interventions
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sotrovimab
Sotrovimab 500 mg given by intravenous infusion over 15 min
sotrovimab
Sotrovimab 500 mg given by intramuscular injection
sotrovimab
Sotrovimab 250 mg given by intramuscular injection
sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 60 min
Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 30 min
Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 15 min
Sotrovimab
Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Eligibility Criteria
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Inclusion Criteria
* Sub-Study participants must be aged 18 years or older at time of consent 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 7 days from onset of symptoms
Exclusion Criteria
* Symptoms consistent with severe COVID-19
* Participants who, in the judgement of the investigator are likely to die in the next 7 days
* Known hypersensitivity to any constituent present in the investigational product
12 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Anniston, Alabama, United States
Investigative Site
Mesa, Arizona, United States
Investigative Site
Tucson, Arizona, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Rolling Hills Estates, California, United States
Investigative Site
Bradenton, Florida, United States
Investigative Site
Doral, Florida, United States
Investigative Site
Doral, Florida, United States
Investigative Site
Gainesville, Florida, United States
Investigative Site
Hialeah, Florida, United States
Investigative Site
Hialeah, 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
Miami, 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
North Miami Beach, Florida, United States
Investigative Site
Ormond Beach, Florida, United States
Investigative Site
Palmetto Bay, Florida, United States
Investigative Sites
Pembroke Pines, Florida, United States
Investigative Site
Pompano Beach, Florida, United States
Investigative Site
Tampa, Florida, United States
Investigative Site
Tampa, Florida, United States
Investigative Site
Atlanta, Georgia, United States
Investigative Site
Idaho Falls, Idaho, United States
Investigative Site
Mishawaka, Indiana, United States
Investigative Site
Sterling Heights, Michigan, United States
Investigative Site
Las Vegas, Nevada, United States
Investigative Site
The Bronx, New York, United States
Investigative Site
High Point, North Carolina, United States
Investigative Site
Mount Airy, North Carolina, United States
Investigative Site
Columbus, Ohio, United States
Investigative Site
Smithfield, Pennsylvania, United States
Investigative Site
Baytown, Texas, United States
Investigative Site
Forney, Texas, United States
Investigative Site
Houston, Texas, United States
Investigative Site
Houston, Texas, United States
Investigative Site
Houston, Texas, United States
Investigative Site
Laredo, Texas, United States
Investigative Site
Mesquite, Texas, United States
Investigative Site
Pharr, Texas, United States
Investigative Site
Kirkland, Washington, United States
Investigative Site
Seattle, Washington, United States
Investigative Site
Limoges, Haute-Vienna, France
Investigative Site
Kyiv, , Ukraine
Countries
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References
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Shapiro AE, Sarkis E, Acloque J, Free A, Gonzalez-Rojas Y, Hussain R, Juarez E, Moya J, Parikh N, Inman D, Cebrik D, Nader A, Noormohamed N, Wang Q, Skingsley A, Austin D, Peppercorn A, Agostini ML, Parra S, Chow S, Mogalian E, Pang PS, Hong DK, Sager JE, Yeh WW, Alexander EL, Gaffney LA, Kohli A. Intramuscular vs Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Noninferiority Clinical Trial. Open Forum Infect Dis. 2023 Jul 14;10(8):ofad354. doi: 10.1093/ofid/ofad354. eCollection 2023 Aug.
Moya J, Temech M, Parra S, Juarez E, Hernandez-Loy R, Gutierrez JCM, Diaz J, Hussain R, Segal S, Xu C, Skingsley A, Schnell G, El-Zailik A, Sager JE, Aldinger M, Alexander EL, Acloque G. Safety, Virology, Pharmacokinetics, and Clinical Experience of High-Dose Intravenous Sotrovimab for the Treatment of Mild to Moderate COVID-19: An Open-Label Clinical Trial. Open Forum Infect Dis. 2023 Jul 10;10(7):ofad344. doi: 10.1093/ofid/ofad344. eCollection 2023 Jul.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Provided Documents
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Document Type: Study Protocol: Main Study
Document Type: Study Protocol: Safety Substudy
Document Type: Statistical Analysis Plan: Safety Substudy
Document Type: Statistical Analysis Plan: Main Study
Other Identifiers
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VIR-7831-5008
Identifier Type: -
Identifier Source: org_study_id
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