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Completed

NCT Number: NCT04517396

FEnofibRate as a Metabolic INtervention for COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fenofibrate/fenofibric acid

Other

The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days.

Placebo

Other

The control intervention will be a placebo, for 10 days.

Usual Care

Other

All participants will otherwise receive usual medical care

Primary outcomes

  1. Primary Hierarchical Composite Endpoint

    Time frame: 30 days

    The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale

Secondary outcomes

  1. 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

    Time frame: Up to 30 days

    Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization

  2. Seven-category Ordinal Scale

    Time frame: At 15 days

    A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death.

  3. Secondary Hierarchical Composite Endpoint

    Time frame: Up to 30 days

    The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed).

Other outcomes

  1. All-Cause Death

    Time frame: Up to 30 days

    Death from any cause during the observation period

  2. Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization

    Time frame: Up to 30 days

    Number of days that participants were alive and out of the hospital during the 30 days following randomization

  3. Exploratory Hierarchical Composite Endpoint

    Time frame: Up to 30 days

    The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • AHEPA University Hospital
  • Biomelab S.A.S.
  • ClÍnica de Marly
  • Clínica Internacional
  • Fundación Cardiomet. Quindio, Colombia
  • Fundación Oftalmológica de Santander. Santander, Colombia
  • G.Gennimatas General Hospital
  • Hospital Central Fuerza Aérea del Perú
  • Hospital Civil de Guadalajara
  • Hospital Militar Central.Coronel Luis Arias Schereiber
  • Hospital Nacional Adolfo Guevara Velasco
  • Hospital Nacional Alberto Sabogal Sologuren
  • Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
  • Hospital Nacional Dos De Mayo
  • Hospital Nacional Edgardo Rebagliati Martins
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Hospital Victor Lazarte Echegaray
  • IPS Centro Científico Asistencial. Barranquilla, Colombia
  • National Center for Advancing Translational Sciences (NCATS)
  • Sotiria Thoracic Diseases Hospital of Athens
  • Thriasio General Hospital of Elefsina
  • Universidad Católica de Santa María
  • Universidad de Santander
  • University Hospital, Alexandroupolis
  • University Hospital, Ioannina
  • University of Arizona

Registry information

Official study title

FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019

Acronym: FERMIN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2020
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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