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

Brii Biosciences Limited48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COVID-19

Interventions

BRII-196 and BRII-198DRUG

BRII-196 and BRII-198 given by intravenous administration

PlaceboDRUG

Placebo given by intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Guangzhou Eighth Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: Up to Day 181

Incidence of serious adverse events (SAEs)

Time frame: Up to Day 181

Change from pre-dose baseline in RBC count

Time frame: Day 29

Change from pre-dose baseline in WBC count

Time frame: Day 29

Change from pre-dose baseline in Platelets count

Time frame: Day 29

Change from pre-dose baseline in Hemoglobin result

Time frame: Day 29

Change from pre-dose baseline in Creatine kinase result

Time frame: Day 29

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

Time frame: Day 29

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

Time frame: Day 8

Secondary Outcomes

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

Time frame: up to Day 29

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

Time frame: up to 26 weeks

Data from ClinicalTrials.gov

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