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NCT Number: NCT04787211

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Ditan Hospital Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRII-196 and BRII-198

Drug

BRII-196 and BRII-198 given by intravenous administration

Placebo

Drug

Placebo given by intravenous administration

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to Day 181

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to Day 181

  3. Change from pre-dose baseline in RBC count

    Time frame: Day 29

  4. Change from pre-dose baseline in WBC count

    Time frame: Day 29

  5. Change from pre-dose baseline in Platelets count

    Time frame: Day 29

  6. Change from pre-dose baseline in Hemoglobin result

    Time frame: Day 29

  7. Change from pre-dose baseline in Creatine kinase result

    Time frame: Day 29

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

    Time frame: Day 29

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

    Time frame: Day 8

Secondary outcomes

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

    Time frame: up to Day 29

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

    Time frame: up to 26 weeks

  3. Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)

    Time frame: up to Day 85

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

  • TSB Therapeutics (Beijing) CO.LTD

Registry information

Official study title

A Phase 2 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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