Status:
WITHDRAWN
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
Lead Sponsor:
Brii Biosciences, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.
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 :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04770467
Start Date
February 1 2021
End Date
October 1 2022
Last Update
March 3 2023
Active Locations (1)
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1
Investigative Site 1
Hong Kong, China