Fenofibrate for Patients With COVID-19 Requiring Hospitalization

Last updated: April 17, 2022
Sponsor: Yaakov Nahmias
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Respiratory Failure

Lung Injury

Treatment

N/A

Clinical Study ID

NCT04661930
0105-20-BRZ; FENOC-005
  • Ages 18-85
  • All Genders

Study Summary

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presumptive positive laboratory test for SARS-CoV-2 based on local laboratory standard
  • Age greater than or equal to 18 years of age
  • Severe COVID-19, defined by:
  • A disease severity score of 3 (Hospitalized, on non-invasive ventilation or highflow oxygen devices) to 4 (Hospitalized, requiring supplemental oxygen). AND o A respiratory SOFA >=1 and increased oxygen requirement compared to baseline amongthose on home O2, a blood oxygen saturation of 93% or less on room air, a ratio of thepartial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) of less than 300mm Hg, respiratory rate >30 breaths/min, or lung infiltrates >50% on chest CT

• Enrollment within 72 hours of presentation of hospital admission or within 72 hours of apositive test result, whichever is later

Exclusion

Exclusion Criteria:

  • Enrollment > 72 hours of admission order or positive test result, whichever is later
  • Admission to the hospital with a respiratory SOFA >=5 , Critical COVID-19, or DiseaseSeverity Score >5 (requiring extracorporeal membrane oxygenation (ECMO), invasivemechanical ventilation, or all)
  • Known hypersensitivity to fenofibrate
  • For female subjects:
  1. Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kitor a blood test
  2. Breastfeeding
  3. Undergoing fertility treatments
  • Patient-reported history or electronic medical record history of kidney disease,defined as:
  1. Any history of dialysis
  2. History of chronic kidney disease stage IV
  3. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at the time ofenrollment
  • Acute pre-renal azotemia at the time of enrollment in the opinion of the investigatoror bedside clinician
  • Most recent mean arterial blood pressure prior to enrollment <65 mmHg
  • Patient-reported history or electronic medical record history of severe liver disease,defined as:
  1. Cirrhosis
  2. History of hepatitis B or C
  3. Documented AST or ALT > 10 times the upper limit of normal measured within 24hours prior to enrollment
  • Patient-reported history or electronic medical record history of gallbladder disease
  • Potassium >5.0 within 24 hours prior to enrollment unless a repeat value was <=5.0
  • Treatment with coumarin anticoagulants (e.g., Warfarin), immunosuppressants (e.g.cisplatin), bile acid resins, or sulfonylurea.
  • Inability to obtain informed consent from participant or legally authorizedrepresentative
  • Enrollment in another blinded randomized clinical trial for COVID

Study Design

Total Participants: 55
Study Start date:
January 01, 2021
Estimated Completion Date:
July 01, 2022

Study Description

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission. Open-label patients will be matched at least 1:10 with observational retrospective Propensity score-matched (PSM) patients' medical files. The double-blinded step will be randomized 2:1 to daily Fenofibrate or placebo for 10 days or hospital discharge.

Connect with a study center

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa,
    Israel

    Active - Recruiting

  • Nazareth Hospital EMMS

    Nazareth,
    Israel

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.