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

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: BRII-196 and BRII-198

• Registration Number: NCT04770467
• Lead Sponsor: Brii Biosciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo in adult subjects with mild-moderate COVID-19	Placebo	-
BRII-196 and BRII-198 in adult subjects with severe COVID-19	BRII-196 and BRII-198	-
Placebo in adult subjects with severe COVID-19	Placebo	-
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19	BRII-196 and BRII-198	-

Primary Outcome Measures

Name	Time	Method
Change from pre-dose baseline in WBC count	Day 29
Change from pre-dose baseline in RBC count	Day 29
Incidence of adverse events (AEs)	Day 29
Incidence of serious adverse events (SAEs)	up to Day 29
Change from pre-dose baseline in Platelets count	Day 29
Change from pre-dose baseline in Hemoglobin result	Day 29
Change from pre-dose baseline in Creatine kinase result	Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result	Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8	Day 8

Secondary Outcome Measures

Name	Time	Method
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
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19	up to Day 29

Trial Locations

Locations (1)

Investigative Site 1; 🇨🇳 Hong Kong, China