Official Title
A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization
Brief Summary

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

Detailed 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.

Unknown status
Corona Virus Disease (COVID-19)
Respiratory Distress Syndrome
SARS-CoV-2 Infection

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
Israel
Locations

Barzilai Medical Center
Ashkelon, Israel

Rambam Health Care Campus
Haifa, Israel

Nazareth Hospital EMMS
Nazareth, Israel

Contacts

Yaakov Nahmias, PhD
+972-2-5494640
ynahmias@cs.huji.ac.il

Avner Ehrlich
+972-54-3181422
avner.ehrlich@mail.huji.ac.il

Yaakov Nahmias
NCT Number
MeSH Terms
COVID-19
Virus Diseases
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Fenofibrate