We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04787211
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04787211
Recruitment Status : Completed
First Posted : March 8, 2021
Last Update Posted : March 3, 2023
Sponsor:
Collaborator:
TSB Therapeutics (Beijing) CO.LTD
Information provided by (Responsible Party):
Brii Biosciences Limited

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2021
Actual Primary Completion Date : December 2, 2021
Actual Study Completion Date : December 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to Day 181 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to Day 181 ]
  3. Change from pre-dose baseline in RBC count [ Time Frame: Day 29 ]
  4. Change from pre-dose baseline in WBC count [ Time Frame: Day 29 ]
  5. Change from pre-dose baseline in Platelets count [ Time Frame: Day 29 ]
  6. Change from pre-dose baseline in Hemoglobin result [ Time Frame: Day 29 ]
  7. Change from pre-dose baseline in Creatine kinase result [ Time Frame: Day 29 ]
  8. Change from pre-dose baseline in Alanine aminotransferase (ALT) result [ Time Frame: Day 29 ]
  9. Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8 [ Time Frame: Day 8 ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04787211


Locations
Layout table for location information
China, Beijing
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing, China, 100015
China, Guangdong
Guangzhou Eighth Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518000
China, Jiangsu
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
China, Yunnan
Yunnan Provincial Infectious Disease Hospital
Kunming, Yunnan, China
Sponsors and Collaborators
Brii Biosciences Limited
TSB Therapeutics (Beijing) CO.LTD
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Brii Biosciences Limited
ClinicalTrials.gov Identifier: NCT04787211    
Other Study ID Numbers: BRII-196-198-004
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Brii Biosciences Limited:
COVID-19 phase 2
monoclonal antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases