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Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19 (BRIGHT Study)

NCT05445934 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1188

Last updated 2023-01-05

No results posted yet for this study

Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 in hospitalized patients with moderate to severe Coronavirus Disease 2019 (COVID-19). A total of about 1188 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.

Conditions

Interventions

DRUG

FB2001

FB2001 for injection will be reconstituted with 100 mL of normal saline prior to intravenous infusion. FB2001 will be administered by IV infusion over approximately 60 minutes.

DRUG

FB2001 placebo

Placebo will be reconstituted with 100 mL of normal saline prior to intravenous infusion. Placebo will be administered by IV infusion over approximately 60 minutes.

Sponsors & Collaborators

  • Frontier Biotechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Cheng Yao · Frontier Biotechnologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2023-11-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445934 on ClinicalTrials.gov