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FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517396
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
University of Arizona
Universidad Católica de Santa María (National Sponsor in Perú)
Hospital Nacional Adolfo Guevara Velasco, Peru
Hospital Nacional Edgardo Rebagliati Martins
Hospital Nacional Alberto Sabogal Sologuren, Peru
Hospital Nacional Guillermo Almenara Irigoyen, Peru
Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
Universidad de Santander, Bucaramanga, Colombia (National Sponsor in Colombia)
National Center for Advancing Translational Sciences (NCATS)
Hospitales Civiles de Guadalajara, Mexico
Hospital 2 de Mayo. Lima, Peru
Hospital de la Fuerza Aérea del Perú. Lima, Peru
Hospital Militar Central "Coronel Luis Arias Schereiber"; Lima, Perú
Hospital Victor Lazarte Echegaray. Lima, Peru
Ioannina University General Hospital. Greece
AHEPA Thessaloniki University General Hospital. Greece
SOTIRIA Athens General University Hospital of Chest Diseases. Greece
THRIASIO Eleusis General Hospital. Greece
Alexandroupolis University General Hospital. Greece
G. GENNIMATAS Athens General Hospital. Greece
Colombia Centro 1: BIOMELAB S.A.S. Barranquilla, Colombia
Fundación Oftalmológica de Santander. Santander, Colombia
IPS Centro Científico Asistencial. Barranquilla, Colombia
Fundación Cardiomet. Quindio, Colombia
Clínica de Marly. Bogotá, Colombia
Clinica Internacional. Lima, Peru
Information provided by (Responsible Party):
Julio A. Chirinos, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 18, 2020
Last Update Posted Date November 2, 2022
Actual Study Start Date  ICMJE August 18, 2020
Actual Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Hierarchical composite endpoint [ Time Frame: Up to 30 days ]
The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to 5 factors: (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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
  • 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 ]
  • 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.
  • Hierarchical composite endpoint [ Time Frame: Up to 30 days ]
    A global rank score similar to the primary endpoint, but using a more comprehensive COVID-19 symptom scale instead of the dyspnea Borg scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 17, 2020)
  • All-Cause Death [ Time Frame: Up to 30 days ]
  • Number of days alive and out of the hospital during the 30 days following randomization [ Time Frame: Up to 30 days ]
  • Hierarchical composite endpoint [ Time Frame: Up to 30 days ]
    A global rank score similar to the primary endpoint, but built only with factors 1-4 of the primary endpoint
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE FEnofibRate as a Metabolic INtervention for COVID-19
Official Title  ICMJE FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Other: Fenofibrate/fenofibric acid
    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.
  • Other: Placebo
    The control intervention will be a placebo, for 10 days.
  • Other: Usual care
    All participants will otherwise receive usual medical care
Study Arms  ICMJE
  • Experimental: Fenofibrate + Usual Care
    The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation
    Interventions:
    • Other: Fenofibrate/fenofibric acid
    • Other: Usual care
  • Placebo Comparator: Placebo + Usual Care
    The randomized intervention will a matching placebo, in combination with usual care.
    Interventions:
    • Other: Placebo
    • Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2022)
701
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2020)
300
Actual Study Completion Date  ICMJE April 30, 2022
Actual Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04517396
Other Study ID Numbers  ICMJE 843729
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not making it available
Current Responsible Party Julio A. Chirinos, University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Arizona
  • Universidad Católica de Santa María (National Sponsor in Perú)
  • Hospital Nacional Adolfo Guevara Velasco, Peru
  • Hospital Nacional Edgardo Rebagliati Martins
  • Hospital Nacional Alberto Sabogal Sologuren, Peru
  • Hospital Nacional Guillermo Almenara Irigoyen, Peru
  • Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
  • Universidad de Santander, Bucaramanga, Colombia (National Sponsor in Colombia)
  • National Center for Advancing Translational Sciences (NCATS)
  • Hospitales Civiles de Guadalajara, Mexico
  • Hospital 2 de Mayo. Lima, Peru
  • Hospital de la Fuerza Aérea del Perú. Lima, Peru
  • Hospital Militar Central "Coronel Luis Arias Schereiber"; Lima, Perú
  • Hospital Victor Lazarte Echegaray. Lima, Peru
  • Ioannina University General Hospital. Greece
  • AHEPA Thessaloniki University General Hospital. Greece
  • SOTIRIA Athens General University Hospital of Chest Diseases. Greece
  • THRIASIO Eleusis General Hospital. Greece
  • Alexandroupolis University General Hospital. Greece
  • G. GENNIMATAS Athens General Hospital. Greece
  • Colombia Centro 1: BIOMELAB S.A.S. Barranquilla, Colombia
  • Fundación Oftalmológica de Santander. Santander, Colombia
  • IPS Centro Científico Asistencial. Barranquilla, Colombia
  • Fundación Cardiomet. Quindio, Colombia
  • Clínica de Marly. Bogotá, Colombia
  • Clinica Internacional. Lima, Peru
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP