BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Bardoxolone Methyl; Placebo
Intervention description: Once-daily administration of bardoxolone methyl (20mg); Once-daily administration of matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All patients, investigators, site personnel, laboratories, and study personnel with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., bardoxolone methyl vs. placebo).
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bardoxolone Methyl

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.
    

Eligibility 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