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

Brii Biosciences

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04770467

BRII-196-198-002

Details and patient eligibility

About

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.

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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0 participants in 4 patient groups, including a placebo group

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

Experimental group

Treatment:

Drug: BRII-196 and BRII-198

Placebo in adult subjects with severe COVID-19

Placebo Comparator group

Treatment:

Drug: Placebo

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