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

COVID-19 Clinical Trial

Official title:

A Phase 2 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787211
• Other study ID #: BRII-196-198-004
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: March 2023
• Source: Brii Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
• Placebo
Placebo given by intravenous administration

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
China	Guangzhou Eighth Hospital, Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Yunnan Provincial Infectious Disease Hospital	Kunming	Yunnan
China	The Third People's Hospital of Shenzhen	Shenzhen	Guangdong
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to Day 181
Primary	Incidence of serious adverse events (SAEs)		Up to Day 181
Primary	Change from pre-dose baseline in RBC count		Day 29
Primary	Change from pre-dose baseline in WBC count		Day 29
Primary	Change from pre-dose baseline in Platelets count		Day 29
Primary	Change from pre-dose baseline in Hemoglobin result		Day 29
Primary	Change from pre-dose baseline in Creatine kinase result		Day 29
Primary	Change from pre-dose baseline in Alanine aminotransferase (ALT) result		Day 29
Primary	Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8		Day 8
Secondary	Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19		up to Day 29
Secondary	Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization		up to 26 weeks
Secondary	Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)		up to Day 85