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

NCT04494646 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-00591
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

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.

Conditions

Covid19

Keywords

Bardoxolone Methyl

Outcome Measures

Primary Outcomes (1)

• Number of Serious Adverse Events

  Day 29

Study Arms (2)

Bardoxolone Methyl

EXPERIMENTAL

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

Drug: Bardoxolone Methyl

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bardoxolone Methyl DRUG

Once-daily administration of bardoxolone methyl (20mg)

Bardoxolone Methyl

Placebo DRUG

Once-daily administration of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory-confirmed COVID-19 infection as determined by polymerase chain reaction (PCR)
• Hospitalized patients that meets one of the following conditions:
• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.); OR
• At rest, blood oxygen saturation ≤ 94%; OR
• Require supplemental oxygen; OR
• Requiring non-invasive ventilation; OR
• Requiring invasive mechanical ventilation for up to 2 days.
• 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
• Participant or legally authorized representative is willing to give informed consent

You may not qualify if:

• Intubated and on invasive mechanical ventilation for three or more days at the time of randomization
• Known left ventricular ejection fraction (LVEF) \<40% or prior hospitalization for heart failure
• Cardiac arrest
• Shock
• Known uncontrolled bacterial, fungal, or non-COVID viral infection
• eGFR \<30 ml/min/1.73 m² or requiring dialysis
• ALT or AST \> 5X ULN
• History of cirrhosis, chronic active hepatitis or severe hepatic disease
• Pregnant or lactating women
• 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.
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Reata Pharmaceuticals, Inc.: collaborator

Study Sites (8)

HSHS St. John's Hospital (Prairie Education and Research Cooperative)

Springfield, Illinois, 62769, United States

Location

SIU School of Medicine

Springfield, Illinois, 62794, United States

Location

NYU Langone Hospital - Brooklyn

Brooklyn, New York, 11220, United States

Location

Coney Island Hospital

Brooklyn, New York, 11235, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

NYU Bellevue Hospital Center

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

bardoxolone methyl

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sripal Bangalore, MD, MHA
• Organization: NYU Langone Health

Sripal.Bangalore@nyulangone.org

(212) 263 3540

Study Officials

• Sripal Bangalore, MD, MHA

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: July 31, 2020
• Study Start: September 8, 2020
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: January 13, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sripal.Bangalore@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (8)