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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04770467
• Other study ID #: BRII-196-198-002
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2021
• Est. completion date: October 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• 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	Investigative Site 1	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Brii Biosciences, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Day 29
Primary	Incidence of serious adverse events (SAEs)		up to Day 29
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 72 weeks
Secondary	Assessment of PK parameters: maximum serum concentration observed (Cmax)		up to Day 85