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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BRII-196 and BRII-198
Placebo
Sponsored by
Brii Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 phase 2, monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Ditan Hospital Capital Medical University
  • Guangzhou Eighth Hospital, Guangzhou Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • The Third People's Hospital of Shenzhen
  • Subei People's Hospital of Jiangsu province
  • Yunnan Provincial Infectious Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BRII-196 and BRII-198 in adult subjects with severe COVID-19

BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19

Placebo in adult subjects with mild-moderate COVID-19

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2021
Last Updated
March 2, 2023
Sponsor
Brii Biosciences Limited
Collaborators
TSB Therapeutics (Beijing) CO.LTD
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1. Study Identification

Unique Protocol Identification Number
NCT04787211
Brief Title
A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brii Biosciences Limited
Collaborators
TSB Therapeutics (Beijing) CO.LTD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 phase 2, monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRII-196 and BRII-198 in adult subjects with severe COVID-19
Arm Type
Experimental
Arm Title
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19
Arm Type
Experimental
Arm Title
Placebo in adult subjects with mild-moderate COVID-19
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BRII-196 and BRII-198
Intervention Description
BRII-196 and BRII-198 given by intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given by intravenous administration
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to Day 181
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to Day 181
Title
Change from pre-dose baseline in RBC count
Time Frame
Day 29
Title
Change from pre-dose baseline in WBC count
Time Frame
Day 29
Title
Change from pre-dose baseline in Platelets count
Time Frame
Day 29
Title
Change from pre-dose baseline in Hemoglobin result
Time Frame
Day 29
Title
Change from pre-dose baseline in Creatine kinase result
Time Frame
Day 29
Title
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
Time Frame
Day 29
Title
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19
Time Frame
up to Day 29
Title
Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization
Time Frame
up to 26 weeks
Title
Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)
Time Frame
up to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong, MD
Organizational Affiliation
Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fujie Zhang, MD
Organizational Affiliation
Co-Study Chair, Beijing Ditan Hospital Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Yuan, MD
Organizational Affiliation
Site-PI, The Third People's Hospital of Shenzhen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xilong Deng, MMS
Organizational Affiliation
Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yao Zhang, MD
Organizational Affiliation
TSB Therapeutics (Beijing) CO.LTD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xingxiang Xu, MD
Organizational Affiliation
Site-PI, Subei People's Hospital of Jiangsu province
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinping Yang, BMED
Organizational Affiliation
Site-PI, Yunnan Provincial Infectious Disease Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Guangzhou Eighth Hospital, Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The Third People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Yunnan Provincial Infectious Disease Hospital
City
Kunming
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

Learn more about this trial

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

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