Back to resultsA Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BRII-196 and BRII-198
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 phase 2, monoclonal antibody
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.
Sites / Locations
- Investigative Site 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
BRII-196 and BRII-198 in adult subjects with severe COVID-19
Placebo 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: maximum serum concentration observed (Cmax)
Full Information
NCT ID
NCT04770467
First Posted
February 22, 2021
Last Updated
March 2, 2023
Sponsor
Brii Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04770467
Brief Title
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brii Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
0 (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
Placebo in adult subjects with severe COVID-19
Arm Type
Placebo Comparator
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
Day 29
Title
Incidence of serious adverse events (SAEs)
Time Frame
up to Day 29
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 72 weeks
Title
Assessment of PK parameters: 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
Yao Zhang, MD
Organizational Affiliation
Brii Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site 1
City
Hong Kong
Country
China
12. IPD Sharing Statement
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 Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
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