drugset / Trial / NCT05445934

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

NCT05445934 ↗

Phase 2/3 Unknown 1188 enrolled Frontier Biotechnologies Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-09-14
Primary completion
2023-11
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject FB2001 Small molecule 200 mg Intravenous

Indications