Clinical trial NCT04770467: A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
Official title: A Phase 2, Randomized, Single-blinded, Placebo-controlled 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Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19 phase 2
monoclonal antibody
Lead sponsor: Brii Biosciences Limited
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 0
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: This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.


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: Day 29
measure: Incidence of serious adverse events (SAEs)
timeFrame: up to Day 29
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 72 weeks
measure: Assessment of PK parameters: maximum serum concentration observed (Cmax)
timeFrame: up to Day 85
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Investigative Site 1
Study officials:
affiliation: Brii Biosciences, Inc.
name: Yao Zhang, MD
role: STUDY_DIRECTOR
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.