This is an open-label run-in followed by a randomized, double-blind drug treatment studyof COVID-19 infected patients requiring inpatient hospital admission.
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.
Drug: TriCor® 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
Other Name: Lipanthyl NT 145mg tablets
Other: Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Other: Usual care
All participants will otherwise receive usual medical care
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
high flow oxygen devices) to 4 (Hospitalized, requiring supplemental oxygen).
AND o A respiratory SOFA >=1 and increased oxygen requirement compared to baseline among
those on home O2, a blood oxygen saturation of 93% or less on room air, a ratio of the
partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) of less than
300 mm 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
a positive test result, whichever is later
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
Disease Severity Score >5 (requiring extracorporeal membrane oxygenation (ECMO),
invasive mechanical ventilation, or all)
- Known hypersensitivity to fenofibrate
- For female subjects:
1. Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection
kit or 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
of enrollment
- Acute pre-renal azotemia at the time of enrollment in the opinion of the
investigator or 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 24
hours 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 authorized
representative
- Enrollment in another blinded randomized clinical trial for COVID
Barzilai Medical Center
Ashkelon, Israel
Rambam Health Care Campus
Haifa, Israel
Nazareth Hospital EMMS
Nazareth, Israel
Yaakov Nahmias, PhD
+972-2-5494640
ynahmias@cs.huji.ac.il
Avner Ehrlich
+972-54-3181422
avner.ehrlich@mail.huji.ac.il