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

March 2, 2023 updated by: Brii Biosciences Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Beijing Ditan Hospital Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Eighth Hospital, Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518000
        • The Third People's Hospital of Shenzhen
    • Jiangsu
      • Yangzhou, Jiangsu, China
        • Subei People's Hospital of Jiangsu province
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan Provincial Infectious Disease Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to Day 181
Up to Day 181
Incidence of serious adverse events (SAEs)
Time Frame: Up to Day 181
Up to Day 181
Change from pre-dose baseline in RBC count
Time Frame: Day 29
Day 29
Change from pre-dose baseline in WBC count
Time Frame: Day 29
Day 29
Change from pre-dose baseline in Platelets count
Time Frame: Day 29
Day 29
Change from pre-dose baseline in Hemoglobin result
Time Frame: Day 29
Day 29
Change from pre-dose baseline in Creatine kinase result
Time Frame: Day 29
Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
Time Frame: Day 29
Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19
Time Frame: up to Day 29
up to Day 29
Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization
Time Frame: up to 26 weeks
up to 26 weeks
Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)
Time Frame: up to Day 85
up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brii Biosciences Limited

Collaborators

TSB Therapeutics (Beijing) CO.LTD

Investigators

  • Study Chair: Nanshan Zhong, MD, Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
  • Principal Investigator: Fujie Zhang, MD, Co-Study Chair, Beijing Ditan Hospital Capital Medical University
  • Principal Investigator: Jing Yuan, MD, Site-PI, The Third People's Hospital of Shenzhen
  • Principal Investigator: Xilong Deng, MMS, Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University
  • Study Director: Yao Zhang, MD, TSB Therapeutics (Beijing) CO.LTD
  • Principal Investigator: Xingxiang Xu, MD, Site-PI, Subei People's Hospital of Jiangsu province
  • Principal Investigator: Xinping Yang, BMED, Site-PI, Yunnan Provincial Infectious Disease Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2021

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRII-196-198-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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