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

Sponsor
Brii Biosciences Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04787211
Collaborator
TSB Therapeutics (Beijing) CO.LTD (Industry)
48
Enrollment
6
Locations
3
Arms
5.4
Actual Duration (Months)
8
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BRII-196 and BRII-198
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jun 20, 2021
Actual Primary Completion Date :
Dec 2, 2021
Actual Study Completion Date :
Dec 2, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of adverse events (AEs) [Up to Day 181]

  2. Incidence of serious adverse events (SAEs) [Up to Day 181]

  3. Change from pre-dose baseline in RBC count [Day 29]

  4. Change from pre-dose baseline in WBC count [Day 29]

  5. Change from pre-dose baseline in Platelets count [Day 29]

  6. Change from pre-dose baseline in Hemoglobin result [Day 29]

  7. Change from pre-dose baseline in Creatine kinase result [Day 29]

  8. Change from pre-dose baseline in Alanine aminotransferase (ALT) result [Day 29]

  9. Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8 [Day 8]

Secondary Outcome Measures

  1. Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19 [up to Day 29]

  2. Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization [up to 26 weeks]

  3. Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax) [up to Day 85]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing Ditan Hospital Capital Medical University Beijing Beijing China 100015
2 Guangzhou Eighth Hospital, Guangzhou Medical University Guangzhou Guangdong China 510000
3 The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510000
4 The Third People's Hospital of Shenzhen Shenzhen Guangdong China 518000
5 Subei People's Hospital of Jiangsu province Yangzhou Jiangsu China
6 Yunnan Provincial Infectious Disease Hospital Kunming Yunnan China

Sponsors and Collaborators

  • Brii Biosciences Limited
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brii Biosciences Limited
ClinicalTrials.gov Identifier:
NCT04787211
Other Study ID Numbers:
  • BRII-196-198-004
First Posted:
Mar 8, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
COVID-19

Study Results

No Results Posted as of Mar 2, 2022