Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
NCT ID: NCT04779879
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
354 participants
INTERVENTIONAL
2021-02-18
2022-04-06
Brief Summary
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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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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
Sotrovimab (Gen1)
Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
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
Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
Interventions
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Sotrovimab (Gen1)
Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
Sotrovimab (Gen2)
Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
69 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
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
Investigative Site
Granada, , Spain
Investigative Site
La Roca del Vallès, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Pozuelo de Alarcón, , Spain
Investigative Site
Vigo, , Spain
Countries
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References
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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
Document Type: Statistical Analysis Plan
Other Identifiers
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GSK Study 216912
Identifier Type: OTHER
Identifier Source: secondary_id
VIR-7831-5006
Identifier Type: -
Identifier Source: org_study_id
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