BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: Bardoxolone Methyl
Once-daily administration of bardoxolone methyl (20mg)
|
Placebo Comparator: 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 |
Drug: Placebo
Once-daily administration of matching placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Serious Adverse Events [Day 29]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | HSHS St. John's Hospital (Prairie Education and Research Cooperative) | Springfield | Illinois | United States | 62769 |
2 | SIU School of Medicine | Springfield | Illinois | United States | 62794 |
3 | NYU Langone Hospital - Brooklyn | Brooklyn | New York | United States | 11220 |
4 | Coney Island Hospital | Brooklyn | New York | United States | 11235 |
5 | Elmhurst Hospital Center | Elmhurst | New York | United States | 11373 |
6 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
7 | NYU Bellevue Hospital Center | New York | New York | United States | 10016 |
8 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- Reata Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Sripal Bangalore, MD, MHA, NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.- 20-00591
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Bardoxolone Methyl | Placebo |
---|---|---|
Arm/Group 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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg) | 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 Placebo: Once-daily administration of matching placebo |
Period Title: Overall Study | ||
STARTED | 21 | 19 |
COMPLETED | 21 | 17 |
NOT COMPLETED | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Bardoxolone Methyl | Placebo | Total |
---|---|---|---|
Arm/Group 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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg) | 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 Placebo: Once-daily administration of matching placebo | Total of all reporting groups |
Overall Participants | 21 | 17 | 38 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
57.3
(16.3)
|
60.5
(12.5)
|
57.4
(14.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
9
42.9%
|
5
29.4%
|
14
36.8%
|
Male |
12
57.1%
|
12
70.6%
|
24
63.2%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
5
23.8%
|
6
35.3%
|
11
28.9%
|
Not Hispanic or Latino |
16
76.2%
|
11
64.7%
|
27
71.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
1
5.9%
|
1
2.6%
|
Asian |
1
4.8%
|
1
5.9%
|
2
5.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
4.8%
|
3
17.6%
|
4
10.5%
|
White |
16
76.2%
|
9
52.9%
|
25
65.8%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
3
14.3%
|
3
17.6%
|
6
15.8%
|
Region of Enrollment (participants) [Number] | |||
United States |
21
100%
|
17
100%
|
38
100%
|
Outcome Measures
Title | Number of Serious Adverse Events |
---|---|
Description | |
Time Frame | Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bardoxolone Methyl | Placebo |
---|---|---|
Arm/Group 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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg) | 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 Placebo: Once-daily administration of matching placebo |
Measure Participants | 21 | 17 |
Number [Adverse Events] |
4
|
6
|
Adverse Events
Time Frame | 29 Days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Bardoxolone Methyl | Placebo | ||
Arm/Group 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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg) | 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 Placebo: Once-daily administration of matching placebo | ||
All Cause Mortality |
||||
Bardoxolone Methyl | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/21 (0%) | 4/17 (23.5%) | ||
Serious Adverse Events |
||||
Bardoxolone Methyl | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/21 (19%) | 6/17 (35.3%) | ||
Cardiac disorders | ||||
Cardiac failure acute, Acute on chronic systolic (congestive) heart failure | 0/21 (0%) | 1/17 (5.9%) | ||
Ventricular tachycardia | 0/21 (0%) | 1/17 (5.9%) | ||
Infections and infestations | ||||
Pneumonia due to covid-19 virus | 1/21 (4.8%) | 0/17 (0%) | ||
Injury, poisoning and procedural complications | ||||
Splenic rupture | 1/21 (4.8%) | 0/17 (0%) | ||
Abdominal wall wound, Worsening abdominal wound | 1/21 (4.8%) | 0/17 (0%) | ||
Splenic laceration | 1/21 (4.8%) | 0/17 (0%) | ||
Nervous system disorders | ||||
Presyncope, Pre-syncope | 0/21 (0%) | 1/17 (5.9%) | ||
Renal and urinary disorders | ||||
Nephrolithiasis, Nephrolithiasis | 1/21 (4.8%) | 0/17 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Hypoxia, Worsening hypoxia | 0/21 (0%) | 1/17 (5.9%) | ||
Respiratory failure Worsening hypoxemic respiratory failure | 0/21 (0%) | 1/17 (5.9%) | ||
Pulmonary Embolism | 0/21 (0%) | 1/17 (5.9%) | ||
Surgical and medical procedures | ||||
Mechanical ventilation, Invasive mechanical ventilation | 1/21 (4.8%) | 0/17 (0%) | ||
Mechanical ventilation | 0/21 (0%) | 1/17 (5.9%) | ||
Other (Not Including Serious) Adverse Events |
||||
Bardoxolone Methyl | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/21 (4.8%) | 1/17 (5.9%) | ||
Infections and infestations | ||||
Fungal Infection | 0/21 (0%) | 1/17 (5.9%) | ||
Nervous system disorders | ||||
Dizziness and Lightheadedness | 1/21 (4.8%) | 0/17 (0%) | ||
Loss of Consciousness | 1/21 (4.8%) | 0/17 (0%) | ||
Blackouts | 1/21 (4.8%) | 0/17 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Sripal Bangalore, MD, MHA |
---|---|
Organization | NYU Langone Health |
Phone | (212) 263 3540 |
Sripal.Bangalore@nyulangone.org |
- 20-00591