A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 moderate COVID-19 and asymptomatic carrier.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brii Biosciences Limited
• Collaborator: TSB Therapeutics (Beijing) CO.LTD

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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