BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Completed · Phase 2 · Has a placebo group
Conditions studied: Covid19
In brief
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.
Key facts
- Study ID
- NCT04494646
- Run by
- NYU Langone Health
- People needed
- 40
- Starts
- 2020-09-08
- Expected to finish
- 2021-01-08
- Last updated by the study team
- 2022-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Laboratory-confirmed COVID-19 infection as determined by polymerase chain reaction (PCR)
- Hospitalized patients that meets one of the following conditions:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.); OR
- At rest, blood oxygen saturation ≤ 94%; OR
- Require supplemental oxygen; OR
- Requiring non-invasive ventilation; OR
- Requiring invasive mechanical ventilation for up to 2 days.
- Age ≥ 18 years. Enrollment of patients ≥70 years of age may be limited (e.g., comprise no more than 10% of all randomized patients), pending safety review by the DSMB and executive committee
- Participant or legally authorized representative is willing to give informed consent
You may not qualify if…
- Intubated and on invasive mechanical ventilation for three or more days at the time of randomization
- Known left ventricular ejection fraction (LVEF) <40% or prior hospitalization for heart failure
- Cardiac arrest
- Shock
- Known uncontrolled bacterial, fungal, or non-COVID viral infection
- eGFR <30 ml/min/1.73 m² or requiring dialysis
- ALT or AST > 5X ULN
- History of cirrhosis, chronic active hepatitis or severe hepatic disease
- Pregnant or lactating women
- Enrolled in other trial of unapproved therapies, unless approved by trial Principal Investigator. In general, co-enrollment will be permitted unless there are safety concerns, mechanistic incompatibility or inability to adjudicate serious adverse events and will be decided on a case by case basis.
- If in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Where it is running
- HSHS St. John's Hospital (Prairie Education and Research Cooperative) — Springfield, Illinois, United States
- SIU School of Medicine — Springfield, Illinois, United States
- NYU Langone Hospital - Brooklyn — Brooklyn, New York, United States
- Coney Island Hospital — Brooklyn, New York, United States
- Elmhurst Hospital Center — Elmhurst, New York, United States
- NYU Winthrop Hospital — Mineola, New York, United States
- NYU Bellevue Hospital Center — New York, New York, United States
- NYU Langone Health — New York, New York, United States
Full record on ClinicalTrials.gov
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