A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
NCT ID: NCT04770467
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-02-28
2022-10-31
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
SINGLE
Study Groups
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BRII-196 and BRII-198 in adult subjects with severe COVID-19
BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
Placebo in adult subjects with severe COVID-19
Placebo
Placebo given by intravenous administration
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19
BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
Placebo in adult subjects with mild-moderate COVID-19
Placebo
Placebo given by intravenous administration
Interventions
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BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
Placebo
Placebo given by intravenous administration
Eligibility Criteria
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Inclusion Criteria
* SARS-CoV-2 infection by PCR ≤ 7 days
* One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)
Exclusion Criteria
* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent
* Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.
18 Years
ALL
No
Sponsors
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Brii Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yao Zhang, MD
Role: STUDY_DIRECTOR
Brii Biosciences, Inc.
Locations
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Investigative Site 1
Hong Kong, , China
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.
Other Identifiers
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BRII-196-198-002
Identifier Type: -
Identifier Source: org_study_id
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