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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04770467

Enrollment

Registered

2021-02-25

Start date

2021-02-28

Completion date

2022-10-31

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19 phase 2, monoclonal antibody

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.

Interventions

DRUGBRII-196 and BRII-198

BRII-196 and BRII-198 given by intravenous administration

DRUGPlacebo

Placebo given by intravenous administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8	Day 8
Change from pre-dose baseline in Hemoglobin result	Day 29
Change from pre-dose baseline in Creatine kinase result	Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result	Day 29
Incidence of adverse events (AEs)	Day 29
Incidence of serious adverse events (SAEs)	up to Day 29
Change from pre-dose baseline in RBC count	Day 29
Change from pre-dose baseline in WBC count	Day 29
Change from pre-dose baseline in Platelets count	Day 29

Secondary

Measure	Time frame
Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization	up to 72 weeks
Assessment of PK parameters: maximum serum concentration observed (Cmax)	up to Day 85
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19	up to Day 29

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026