A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
Overview
- Phase
- Phase 2
- Intervention
- BRII-196 and BRII-198
- Conditions
- COVID-19
- Sponsor
- Brii Biosciences, Inc.
- Locations
- 1
- Primary Endpoint
- Change from pre-dose baseline in WBC count
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
BRII-196 and BRII-198 in adult subjects with severe COVID-19
Intervention: BRII-196 and BRII-198
Placebo in adult subjects with severe COVID-19
Intervention: Placebo
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19
Intervention: BRII-196 and BRII-198
Placebo in adult subjects with mild-moderate COVID-19
Intervention: Placebo
Outcomes
Primary Outcomes
Change from pre-dose baseline in WBC count
Time Frame: Day 29
Change from pre-dose baseline in RBC count
Time Frame: Day 29
Incidence of adverse events (AEs)
Time Frame: Day 29
Incidence of serious adverse events (SAEs)
Time Frame: up to Day 29
Change from pre-dose baseline in Platelets count
Time Frame: Day 29
Change from pre-dose baseline in Hemoglobin result
Time Frame: Day 29
Change from pre-dose baseline in Creatine kinase result
Time Frame: Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
Time Frame: Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
Time Frame: Day 8
Secondary Outcomes
- Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19(up to Day 29)
- Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization(up to 72 weeks)
- Assessment of PK parameters: maximum serum concentration observed (Cmax)(up to Day 85)