NCT04770467

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

February 22, 2021

Last Update Submit

March 2, 2023

Conditions

COVID-19

Keywords

COVID-19 phase 2monoclonal antibody

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

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

    Day 8

Secondary Outcomes (3)

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

    up to Day 29

  • 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

Study Arms (4)

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

EXPERIMENTAL
Drug: BRII-196 and BRII-198

Placebo in adult subjects with severe COVID-19

PLACEBO COMPARATOR
Drug: Placebo

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

EXPERIMENTAL
Drug: BRII-196 and BRII-198

Placebo in adult subjects with mild-moderate COVID-19

EXPERIMENTAL
Drug: Placebo

Interventions

BRII-196 and BRII-198DRUG

BRII-196 and BRII-198 given by intravenous administration

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

Placebo given by intravenous administration

Placebo in adult subjects with mild-moderate COVID-19Placebo in adult subjects with severe COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigative Site 1

Hong Kong, China

Location

Related Publications (1)

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

amubarvimabromlusevimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yao Zhang, MD

    Brii Biosciences, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

February 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

CN(1)