CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Bardoxolone Methyl +1 moredrug
Likely dose
Bardoxolone Methyl 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04494646
NCT04494646Phase 2Completed
CompareCT.gov

BARCONA: A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)

NYU Langone Health·interventional·Posted Jul 31, 2020·Updated Jan 13, 2022

In Brief

A Phase 2 clinical trial evaluating Bardoxolone Methyl and Placebo for Covid19. Completed, enrolled 40 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
CollaboratorsReata Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 31, 2020
Enrollment StartSep 8, 2020
Primary CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.9 years ago

Interventions

Bardoxolone Methyldrug

Once-daily administration of bardoxolone methyl (20mg)

Placebodrug

Once-daily administration of matching placebo