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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494646
• Other study ID #: 20-00591
• Status: Completed
• Phase: Phase 2
• Start date: September 8, 2020
• Est. completion date: January 8, 2021

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Covid19

Intervention

Drug:
• Bardoxolone Methyl
Once-daily administration of bardoxolone methyl (20mg)
• Placebo
Once-daily administration of matching placebo

Locations

Country	Name	City	State
United States	Coney Island Hospital	Brooklyn	New York
United States	NYU Langone Hospital - Brooklyn	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	HSHS St. John's Hospital (Prairie Education and Research Cooperative)	Springfield	Illinois
United States	SIU School of Medicine	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Reata Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events		Day 29