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

Sponsor

Brii Biosciences, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04770467

Collaborator

(none)

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: BRII-196 and BRII-198 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BRII-196 and BRII-198 in adult subjects with severe COVID-19	Drug: BRII-196 and BRII-198 BRII-196 and BRII-198 given by intravenous administration
Placebo Comparator: Placebo in adult subjects with severe COVID-19	Drug: Placebo Placebo given by intravenous administration
Experimental: BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19	Drug: BRII-196 and BRII-198 BRII-196 and BRII-198 given by intravenous administration
Experimental: Placebo in adult subjects with mild-moderate COVID-19	Drug: Placebo Placebo given by intravenous administration

Outcome Measures

Primary Outcome Measures

Incidence of adverse events (AEs) [Day 29]
Incidence of serious adverse events (SAEs) [up to Day 29]
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 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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site 1	Hong Kong		China

Sponsors and Collaborators

Brii Biosciences, Inc.

Investigators

Study Director: Yao Zhang, MD, Brii Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brii Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT04770467

Other Study ID Numbers:

BRII-196-198-002

First Posted:

Feb 25, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Brii Biosciences, Inc.

COVID-19 phase 2

monoclonal antibody

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 2, 2022