A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19

Brii Biosciences, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

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 (1)

Investigative Site 1

Hong Kong, China

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: Day 29

Incidence of serious adverse events (SAEs)

Time frame: up to Day 29

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 72 weeks

Data from ClinicalTrials.gov

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