Fenofibrate for Patients With COVID-19 Requiring Hospitalization

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebrew University of Jerusalem
• Collaborator: Barzilai Medical Center
• Treatments: Fenofibrate

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

• Admission to the hospital with a respiratory SOFA >=1 and increased oxygen requirement compared to baseline among those on home O2

• 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 or Disease Severity Score >=5 (requiring noninvasive mechanical ventilation, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or all)

• Known hypersensitivity to fenofibrate

• For female subjects:

1. Breastfeeding

2. 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, immunosuppressants, or bile acid resins

• Inability to obtain informed consent from participant or legally authorized representative

• Enrollment in another blinded randomized clinical trial for COVID-19