A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19

• Status: Withdrawn
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Brii Biosciences, Inc.

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.