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

• Status: Completed
• Trial end date: 2021-01-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: Reata Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Laboratory-confirmed COVID-19 infection as determined by polymerase chain reaction (PCR)

2. Hospitalized patients that meets one of the following conditions:

1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.); OR

2. At rest, blood oxygen saturation ≤ 94%; OR

3. Require supplemental oxygen; OR

4. Requiring non-invasive ventilation; OR

5. Requiring invasive mechanical ventilation for up to 2 days.

3. 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

4. Participant or legally authorized representative is willing to give informed consent

Exclusion Criteria:

1. Intubated and on invasive mechanical ventilation for three or more days at the time of randomization

2. Known left ventricular ejection fraction (LVEF) <40% or prior hospitalization for heart failure

3. Cardiac arrest

4. Shock

5. Known uncontrolled bacterial, fungal, or non-COVID viral infection

6. eGFR <30 ml/min/1.73 m² or requiring dialysis

7. ALT or AST > 5X ULN

8. History of cirrhosis, chronic active hepatitis or severe hepatic disease

9. Pregnant or lactating women

10. 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.

11. 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