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Trial record 1 of 1 for:    BRII-196-198-004
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A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

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ClinicalTrials.gov Identifier: NCT04787211
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
TSB Therapeutics (Beijing) CO.LTD
Information provided by (Responsible Party):
Brii Biosciences Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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




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 ]


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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

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


Contacts
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Contact: Lili Chen +86 10 6299 8808 lili.chen@briibio.com

Locations
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China, Beijing
Beijing Ditan Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Principal Investigator: Fujie Zhang, MD         
China, Guangdong
Guangzhou Eighth Hospital, Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Principal Investigator: Xilong Deng, MMS         
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510000
Principal Investigator: Nanshan Zhong, MD         
The Third People's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China, 518000
Principal Investigator: Yuan Jing, MD         
China, Jiangsu
Subei People's Hospital of Jiangsu province Recruiting
Yangzhou, Jiangsu, China
Principal Investigator: Xingxiang Xu, MD         
China, Yunnan
Yunnan Provincial Infectious Disease Hospital Not yet recruiting
Kunming, Yunnan, China
Principal Investigator: Xinping Yang, BMED         
Sponsors and Collaborators
Brii Biosciences Limited
TSB Therapeutics (Beijing) CO.LTD
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases