Status:
COMPLETED
A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
TSB Therapeutics (Beijing) CO.LTD
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to mode...
Eligibility Criteria
Inclusion
- Subject ≥ 18 years, signing the informed consent.
- 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
- Recurring COVID-19 patients
- 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
Key Trial Info
Start Date :
June 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04787211
Start Date
June 20 2021
End Date
December 2 2021
Last Update
March 3 2023
Active Locations (6)
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1
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100015
2
Guangzhou Eighth Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
4
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518000