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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 : Enrolling by invitation
First Posted : August 18, 2020
Last Update Posted : October 4, 2021
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 Science (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

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.

Condition or disease Intervention/treatment Phase
Covid19 Other: Fenofibrate/fenofibric acid Other: Placebo Other: Usual care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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: Usual care
All participants will otherwise receive usual medical care

Placebo Comparator: Placebo + Usual Care
The randomized intervention will a matching placebo, in combination with usual care.
Other: Placebo
The control intervention will be a placebo, for 10 days.

Other: Usual care
All participants will otherwise receive usual medical care




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 ]
  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. 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


Other Outcome Measures:
  1. All-Cause Death [ Time Frame: Up to 30 days ]
  2. Number of days alive and out of the hospital during the 30 days following randomization [ Time Frame: Up to 30 days ]
  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517396


Locations
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United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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 Science (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
Publications:
Ehrlich E, Uhl S, Ioannidis K, Hofree M, tenOever B, Nahmias Y. The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium. Cell Sneak Peak (submission only). 2020
PASS 16 Power Analysis and Sample Size Software. NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 2018
Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. In: Statistics for Biology and Health. New York, NY: Springer; 2001
Little RJ. Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association. 1995;90:1112-1121
Ting R-D, Keech A. Fenofibrate and renal disease: clinical effects in diabetes. Clinical Lipidology. 2013;8(6):669-680

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Responsible Party: Julio A. Chirinos, Associate Professor of Medicine at the Hospital of the University of Pennsylvania, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04517396    
Other Study ID Numbers: 843729
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not making it available

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Fenofibrate
Fenofibric acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anticholesteremic Agents