drugset / Trial / NCT04494646

BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)

NCT04494646 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

This multi-center, double-blind, placebo-controlled, randomized Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in patients hospitalized with confirmed COVID-19. The trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.

Timeline

Start
2020-09-08
Primary completion
2021-01-08
Completion
2021-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 20 mg —

Indications