A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
NCT ID: NCT04787211
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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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2021-06-20
2021-12-02
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
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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TSB Therapeutics (Beijing) CO.LTD
INDUSTRY
Brii Biosciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Nanshan Zhong, MD
Role: STUDY_CHAIR
Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
Fujie Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Co-Study Chair, Beijing Ditan Hospital Capital Medical University
Jing Yuan, MD
Role: PRINCIPAL_INVESTIGATOR
Site-PI, The Third People's Hospital of Shenzhen
Xilong Deng, MMS
Role: PRINCIPAL_INVESTIGATOR
Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University
Yao Zhang, MD
Role: STUDY_DIRECTOR
TSB Therapeutics (Beijing) CO.LTD
Xingxiang Xu, MD
Role: PRINCIPAL_INVESTIGATOR
Site-PI, Subei People's Hospital of Jiangsu province
Xinping Yang, BMED
Role: PRINCIPAL_INVESTIGATOR
Site-PI, Yunnan Provincial Infectious Disease Hospital
Locations
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Guangzhou Eighth Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Yunnan Provincial Infectious Disease Hospital
Kunming, Yunnan, 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-196-198-004
Identifier Type: -
Identifier Source: org_study_id
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