Last updated: April 17, 2022
Sponsor: Yaakov Nahmias
Overall Status: Active - Recruiting
Phase
3
Condition
Covid-19
Respiratory Failure
Lung Injury
Treatment
N/AClinical Study ID
NCT04661930
0105-20-BRZ; FENOC-005
Ages 18-85 All Genders
Study Summary
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:
- Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kitor a blood test
- Breastfeeding
- Undergoing fertility treatments
- Patient-reported history or electronic medical record history of kidney disease,defined as:
- Any history of dialysis
- History of chronic kidney disease stage IV
- 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:
- Cirrhosis
- History of hepatitis B or C
- 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
Connect with a study center
Barzilai Medical Center
Ashkelon, 7830604
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa,
IsraelActive - Recruiting
Nazareth Hospital EMMS
Nazareth,
IsraelActive - Recruiting
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