Back to resultsBARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bardoxolone Methyl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Bardoxolone Methyl
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- HSHS St. John's Hospital (Prairie Education and Research Cooperative)
- SIU School of Medicine
- NYU Langone Hospital - Brooklyn
- Coney Island Hospital
- Elmhurst Hospital Center
- NYU Winthrop Hospital
- NYU Bellevue Hospital Center
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bardoxolone Methyl
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of Serious Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT04494646
First Posted
July 29, 2020
Last Updated
January 11, 2022
Sponsor
NYU Langone Health
Collaborators
Reata Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04494646
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Reata Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Bardoxolone Methyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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).
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bardoxolone Methyl
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bardoxolone Methyl
Intervention Description
Once-daily administration of bardoxolone methyl (20mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once-daily administration of matching placebo
Primary Outcome Measure Information:
Title
Number of Serious Adverse Events
Time Frame
Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sripal Bangalore, MD, MHA
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
HSHS St. John's Hospital (Prairie Education and Research Cooperative)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
NYU Langone Hospital - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Coney Island Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
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