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

NCT04787211 | Completed Phase 2

• 1 other identifier: BRII-196-198-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID-19

Keywords

COVID-19 phase 2; monoclonal antibody

Outcome Measures

Primary Outcomes (9)

• Incidence of adverse events (AEs)

  Up to Day 181

• Incidence of serious adverse events (SAEs)

  Up to Day 181

• Change from pre-dose baseline in RBC count

  Day 29

• Change from pre-dose baseline in WBC count

  Day 29

• Change from pre-dose baseline in Platelets count

  Day 29

• Change from pre-dose baseline in Hemoglobin result

  Day 29

• Change from pre-dose baseline in Creatine kinase result

  Day 29

• Change from pre-dose baseline in Alanine aminotransferase (ALT) result

  Day 29

• Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8

  Day 8

Secondary Outcomes (3)

• Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19

  up to Day 29

• Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization

  up to 26 weeks

• Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)

  up to Day 85

Study Arms (3)

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

EXPERIMENTAL

Drug: BRII-196 and BRII-198

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

EXPERIMENTAL

Drug: BRII-196 and BRII-198

Placebo in adult subjects with mild-moderate COVID-19

EXPERIMENTAL

Drug: Placebo

Interventions

BRII-196 and BRII-198 DRUG

BRII-196 and BRII-198 given by intravenous administration

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

Placebo DRUG

Placebo given by intravenous administration

Placebo in adult subjects with mild-moderate COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brii Biosciences Limited: lead
• TSB Therapeutics (Beijing) CO.LTD: collaborator

Study Sites (6)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Guangzhou Eighth Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 518000, China

Location

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, China

Location

Yunnan Provincial Infectious Disease Hospital

Kunming, Yunnan, China

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

amubarvimab; romlusevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nanshan Zhong, MD

  Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Yao Zhang, MD

  TSB Therapeutics (Beijing) CO.LTD

  STUDY DIRECTOR

• Xingxiang Xu, MD

  Site-PI, Subei People's Hospital of Jiangsu province

  PRINCIPAL INVESTIGATOR

• Xinping Yang, BMED

  Site-PI, Yunnan Provincial Infectious Disease Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: June 20, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)