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

Phase 2

Completed

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

• Registration Number: NCT04787211
• Lead Sponsor: Brii Biosciences Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Study Start: 2021-06-20
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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
BRII-196 and BRII-198 in adult subjects with severe COVID-19	BRII-196 and BRII-198	-
Placebo in adult subjects with mild-moderate 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 Platelets count	Day 29
Incidence of adverse events (AEs)	Up to Day 181
Change from pre-dose baseline in RBC count	Day 29
Change from pre-dose baseline in WBC count	Day 29
Change from pre-dose baseline in Creatine kinase result	Day 29
Incidence of serious adverse events (SAEs)	Up to Day 181
Change from pre-dose baseline in Hemoglobin 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
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 26 weeks
Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)	up to Day 85

Trial Locations

Locations (6)

Guangzhou Eighth Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Ditan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Third People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

Subei People's Hospital of Jiangsu province; 🇨🇳 Yangzhou, Jiangsu, China

Yunnan Provincial Infectious Disease Hospital; 🇨🇳 Kunming, Yunnan, China