Status:
COMPLETED
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Reata Pharmaceuticals, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. ...
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, clini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04494646
Start Date
September 8 2020
End Date
January 8 2021
Last Update
January 13 2022
Active Locations (8)
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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