Clinical trial NCT04494646: BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: Bardoxolone Methyl
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Reata Pharmaceuticals, Inc.
First posted: 2020-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: HSHS St. John's Hospital (Prairie Education and Research Cooperative)
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Brooklyn
country: United States
facility: NYU Langone Hospital - Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Coney Island Hospital
state: New York
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: New York
country: United States
facility: NYU Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sripal Bangalore, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: