Clinical trial NCT04517396: FEnofibRate as a Metabolic INtervention for COVID-19
Official title: FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Universidad Católica de Santa María
name: Hospital Nacional Adolfo Guevara Velasco
name: Hospital Nacional Edgardo Rebagliati Martins
name: Hospital Nacional Alberto Sabogal Sologuren
name: Hospital Nacional Guillermo Almenara Irigoyen
name: Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
name: Universidad de Santander
name: National Center for Advancing Translational Sciences (NCATS)
name: Hospital Civil de Guadalajara
name: Hospital Nacional Dos De Mayo
name: Hospital Central Fuerza Aérea del Perú
name: Hospital Militar Central.Coronel Luis Arias Schereiber
name: Hospital Victor Lazarte Echegaray
name: University Hospital, Ioannina
name: AHEPA University Hospital
name: Sotiria Thoracic Diseases Hospital of Athens
name: Thriasio General Hospital of Elefsina
name: University Hospital, Alexandroupolis
name: G.Gennimatas General Hospital
name: Biomelab S.A.S.
name: Fundación Oftalmológica de Santander. Santander, Colombia
name: IPS Centro Científico Asistencial. Barranquilla, Colombia
name: Fundación Cardiomet. Quindio, Colombia
name: ClÍnica de Marly
name: Clínica Internacional
First posted: 2020-08-18
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease (\[CKD\]) to improve clinical outcomes in patients with COVID-19.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of COVID-19, based on: (a) A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or (b) Considered by the primary team to be a Person Under Investigation undergoing testing for COVID-19 with a high clinical probability, in addition to compatible pulmonary infiltrates on chest x-ray (bilateral, intersticial or ground glass opacities) or chest CT.
* Able to provide informed consent.
* Fewer than 14 days since symptom onset.

Exclusion Criteria:

* Known pregnancy or breastfeeding
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or undergoing dialysis (CKD stages 4-5).
* History of active liver disease, cholelithiasis, uncontrolled hypothyroidism, or rhabdomyolysis (suspected or confirmed). Patients with a history of hypothyroidism receiving a stable dose of thyroid replacement therapy for at least 6 weeks, with a documented normal TSH (primary hypothyroidism) or free thyroxine (secondary or tertiary hypothyroidism) level at least 6 weeks after the last dose change will be considered eligible for enrollment.
* Known hypersensitivity to fenofibrate or fenofibric acid.
* Ongoing treatment with fenofibrate, clofibrate, warfarin and other coumarin anticoagulants, glimepiride, cyclosporine, tacrolimus
* Use of statins other than simvastatin, pravastatin or atorvastatin ≤40 mg/d or rosuvastatin ≤20 mg/d
* Prisoners/incarcerated individuals
* Inability to read, write or no access to a smart phone, computer or tablet device
* Intubated patients.

Primary outcomes:
measure: Primary Hierarchical Composite Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Number of Days Alive, Out of the Intensive Care Unit, Free of Mechanical Ventilation/Extracorporeal Membrane Oxygenation, or Maximal Available Respiratory Support in the 30 Days Following Randomization
timeFrame: Up to 30 days
measure: Seven-category Ordinal Scale
timeFrame: At 15 days
measure: Secondary Hierarchical Composite Endpoint
timeFrame: Up to 30 days
Other outcomes:
measure: All-Cause Death
timeFrame: Up to 30 days
measure: Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization
timeFrame: Up to 30 days
measure: Exploratory Hierarchical Composite Endpoint
timeFrame: Up to 30 days
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
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