fenofibrate for patients with covid-19 requiring hospitalization

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

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.

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.

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