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

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ClinicalTrials.gov Identifier: NCT04494646
Recruitment Status : Completed
First Posted : July 31, 2020
Last Update Posted : May 12, 2021
Sponsor:
Collaborator:
Reata Pharmaceuticals, Inc.
Information provided by (Responsible Party):
NYU Langone Health

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
Covid19 Drug: Bardoxolone Methyl Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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).
Primary Purpose: Treatment
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)
Actual Study Start Date : September 8, 2020
Actual Primary Completion Date : January 8, 2021
Actual Study Completion Date : January 8, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of Serious Adverse Events [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. Average number of renal replacement therapy (RRT)-free days [ Time Frame: Day 29 ]
  2. Average number of mechanical ventilation-free days [ Time Frame: Day 29 ]
  3. Incidence of All-Cause Mortality [ Time Frame: Day 29 ]
  4. Proportion of participants who experienced deterioration from baseline [ Time Frame: Day 29 ]

    Deterioration is defined by a 1-point worsening scale:

    0- Uninfected; no viral RNA detected, 1- Asymptomatic; viral RNA detected, 2- Symptomatic; Independent, 3- Symptomatic; assistance needed, 4- Hospitalized; no oxygen therapy, 5- Hospitalized; oxygen by mask or nasal prongs, 6- Hospitalized; oxygen by NIV or High flow, 7- Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200, 8- Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors, 9- Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO, 10- Death




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Laboratory-confirmed COVID-19 infection as determined by polymerase chain reaction (PCR)
  2. Hospitalized patients that meets one of the following conditions:

    1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.); OR
    2. At rest, blood oxygen saturation ≤ 94%; OR
    3. Require supplemental oxygen; OR
    4. Requiring non-invasive ventilation; OR
    5. Requiring invasive mechanical ventilation for up to 2 days.
  3. 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
  4. Participant or legally authorized representative is willing to give informed consent

Exclusion Criteria:

  1. Intubated and on invasive mechanical ventilation for three or more days at the time of randomization
  2. Known left ventricular ejection fraction (LVEF) <40% or prior hospitalization for heart failure
  3. Cardiac arrest
  4. Shock
  5. Known uncontrolled bacterial, fungal, or non-COVID viral infection
  6. eGFR <30 ml/min/1.73 m² or requiring dialysis
  7. ALT or AST > 5X ULN
  8. History of cirrhosis, chronic active hepatitis or severe hepatic disease
  9. Pregnant or lactating women
  10. 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.
  11. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494646


Locations
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United States, Illinois
HSHS St. John's Hospital (Prairie Education and Research Cooperative)
Springfield, Illinois, United States, 62769
SIU School of Medicine
Springfield, Illinois, United States, 62794
United States, New York
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States, 11220
Coney Island Hospital
Brooklyn, New York, United States, 11235
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
NYU Winthrop Hospital
Mineola, New York, United States, 11501
NYU Bellevue Hospital Center
New York, New York, United States, 10016
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Reata Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Sripal Bangalore, MD, MHA NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04494646    
Other Study ID Numbers: 20-00591
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Bardoxolone Methyl
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases