Fenofibrate for Patients With COVID-19 Requiring Hospitalization (FENOC)

Yaakov Nahmias

Status and phase: Unknown; Phase 3

Conditions: Corona Virus Disease (COVID-19); Respiratory Distress Syndrome; SARS-CoV-2 Infection

Treatments: Other: Placebo; Drug: TriCor® 145mg tablets; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04661930

0105-20-BRZ FENOC-005;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

55 participants in 3 patient groups, including a placebo group

Fenofibrate + Usual Care

Experimental group

Description:

Participants in this arm will receive the study drug, Fenofibrate, in combination with usual care.

Treatment:

Drug: TriCor® 145mg tablets

Other: Usual care

Placebo + Usual Care

Placebo Comparator group

Description:

Participants in this arm will receive placebo treatment, in combination with usual care.

Treatment:

Other: Placebo

Other: Usual care

Usual Care (Observetional)

No Intervention group

Description:

Participants in this arm will receive the usual care and be compared by their medical records and laboratory results