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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-01-08

Brief Summary

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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.

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Detailed Description

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Following randomization on Day 1, patients will be assessed while hospitalized on Days 3, 5, 8, 11, 15, 22, and 29. Assessments will include clinical status assessments, vital sign measurements, clinical chemistry collection, and adverse event collection. Patients that recover prior to Day 29 will complete an end-of-treatment visit. Patients will have an in-person follow-up on Day 29, regardless of treatment adherence and recovery status prior to Day 29, and a safety follow-up 60 days after randomization for clinical status assessments, vital sign measurements, clinical chemistry collection, and adverse event collection. Follow-up in-person visits are preferred but recognizing quarantine and other factors may limit the subject's ability to return to the site for the visit. In this case, the visit may be performed by phone. An independent Data and Safety Monitoring Board will advise the study leadership on safety aspects and overall progress of the study.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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).

Study Groups

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Bardoxolone Methyl

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

Group Type EXPERIMENTAL

Bardoxolone Methyl

Intervention Type DRUG

Once-daily administration of bardoxolone methyl (20mg)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once-daily administration of matching placebo

Interventions

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Bardoxolone Methyl

Once-daily administration of bardoxolone methyl (20mg)

Intervention Type DRUG

Placebo

Once-daily administration of matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No