Status:
UNKNOWN
Fenofibrate for Patients With COVID-19 Requiring Hospitalization
Lead Sponsor:
Yaakov Nahmias
Collaborating Sponsors:
Barzilai Medical Center
Rambam Health Care Campus
Conditions:
Corona Virus Disease (COVID-19)
Respiratory Distress Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
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 le...
Eligibility Criteria
Inclusion
- 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
- 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:
- Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kit or 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 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:
- Cirrhosis
- History of hepatitis B or C
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04661930
Start Date
January 1 2021
End Date
July 1 2022
Last Update
April 19 2022
Active Locations (3)
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1
Barzilai Medical Center
Ashkelon, Israel, 7830604
2
Rambam Health Care Campus
Haifa, Israel
3
Nazareth Hospital EMMS
Nazareth, Israel