Trial Outcomes & Findings for BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) (NCT NCT04494646)

NCT ID: NCT04494646

Last Updated: 2022-01-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 29
• Results posted on: 2022-01-13

Participant Flow

Participant milestones

Measure	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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)	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 Placebo: Once-daily administration of matching placebo
Overall Study STARTED	21	19
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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 Bardoxolone Methyl: Once-daily administration of bardoxolone methyl (20mg)	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 Placebo: Once-daily administration of matching placebo
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bardoxolone Methyl n=21 Participants 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)	Placebo n=17 Participants 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 n=38 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 16.3 • n=5 Participants	60.5 years STANDARD_DEVIATION 12.5 • n=7 Participants	57.4 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	17 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Outcome measures

Measure	Bardoxolone Methyl n=21 Participants 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)	Placebo n=17 Participants 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
Number of Serious Adverse Events	4 Adverse Events	6 Adverse Events

Adverse Events

Bardoxolone Methyl

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Measure	Bardoxolone Methyl n=21 participants at risk 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)	Placebo n=17 participants at risk 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
Nervous system disorders Presyncope, Pre-syncope	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Respiratory, thoracic and mediastinal disorders Hypoxia, Worsening hypoxia	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Cardiac disorders Cardiac failure acute, Acute on chronic systolic (congestive) heart failure	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Renal and urinary disorders Nephrolithiasis, Nephrolithiasis	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Injury, poisoning and procedural complications Splenic rupture	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Surgical and medical procedures Mechanical ventilation, Invasive mechanical ventilation	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Injury, poisoning and procedural complications Abdominal wall wound, Worsening abdominal wound	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Respiratory, thoracic and mediastinal disorders Respiratory failure Worsening hypoxemic respiratory failure	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Surgical and medical procedures Mechanical ventilation	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Cardiac disorders Ventricular tachycardia	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Infections and infestations Pneumonia due to covid-19 virus	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Injury, poisoning and procedural complications Splenic laceration	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days

Other adverse events

Measure	Bardoxolone Methyl n=21 participants at risk 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)	Placebo n=17 participants at risk 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
Nervous system disorders Dizziness and Lightheadedness	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Infections and infestations Fungal Infection	0.00% 0/21 • 29 Days	5.9% 1/17 • 29 Days
Nervous system disorders Loss of Consciousness	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days
Nervous system disorders Blackouts	4.8% 1/21 • 29 Days	0.00% 0/17 • 29 Days

Additional Information

Sripal Bangalore, MD, MHA

NYU Langone Health

Phone: (212) 263 3540

Email: Sripal.Bangalore@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place