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

Brii Biosciences

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: BRII-196 and BRII-198

Study type: Interventional

Funder types: Industry

Identifiers

NCT04787211

BRII-196-198-004

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

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

Experimental group

Treatment:

Drug: BRII-196 and BRII-198

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

Experimental group

Treatment:

Drug: BRII-196 and BRII-198

Placebo in adult subjects with mild-moderate COVID-19

Experimental group

Treatment:

Drug: Placebo