Clinical trial NCT04787211: A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19 phase 2
monoclonal antibody
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: TSB Therapeutics (Beijing) CO.LTD
First posted: 2021-03-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to Day 181
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to Day 181
measure: Change from pre-dose baseline in RBC count
timeFrame: Day 29
measure: Change from pre-dose baseline in WBC count
timeFrame: Day 29
measure: Change from pre-dose baseline in Platelets count
timeFrame: Day 29
measure: Change from pre-dose baseline in Hemoglobin result
timeFrame: Day 29
measure: Change from pre-dose baseline in Creatine kinase result
timeFrame: Day 29
measure: Change from pre-dose baseline in Alanine aminotransferase (ALT) result
timeFrame: Day 29
measure: Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19
timeFrame: up to Day 29
measure: Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization
timeFrame: up to 26 weeks
measure: Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)
timeFrame: up to Day 85
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Eighth Hospital, Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
state: Guangdong
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
city: Kunming
country: China
facility: Yunnan Provincial Infectious Disease Hospital
state: Yunnan
Study officials:
affiliation: Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, MD
role: STUDY_CHAIR
affiliation: Co-Study Chair, Beijing Ditan Hospital Capital Medical University
name: Fujie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Site-PI, The Third People's Hospital of Shenzhen
name: Jing Yuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University
name: Xilong Deng, MMS
role: PRINCIPAL_INVESTIGATOR
affiliation: TSB Therapeutics (Beijing) CO.LTD
name: Yao Zhang, MD
role: STUDY_DIRECTOR
affiliation: Site-PI, Subei People's Hospital of Jiangsu province
name: Xingxiang Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Site-PI, Yunnan Provincial Infectious Disease Hospital
name: Xinping Yang, BMED
role: PRINCIPAL_INVESTIGATOR
References:
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.