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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate/fenofibric acid
Placebo
Usual care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fenofibrate + Usual Care

Placebo + Usual Care

Arm Description

The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation

The randomized intervention will a matching placebo, in combination with usual care.

Outcomes

Primary Outcome Measures

Primary Hierarchical Composite Endpoint
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 Outcome Measures

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
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
Seven-category Ordinal Scale
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.
Secondary Hierarchical Composite Endpoint
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).

Full Information

First Posted
August 17, 2020
Last Updated
March 22, 2023
Sponsor
University of Pennsylvania
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 General Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT04517396
Brief Title
FEnofibRate as a Metabolic INtervention for COVID-19
Acronym
FERMIN
Official Title
FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
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 General Hospital, 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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenofibrate + Usual Care
Arm Type
Experimental
Arm Description
The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation
Arm Title
Placebo + Usual Care
Arm Type
Placebo Comparator
Arm Description
The randomized intervention will a matching placebo, in combination with usual care.
Intervention Type
Other
Intervention Name(s)
Fenofibrate/fenofibric acid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control intervention will be a placebo, for 10 days.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
All participants will otherwise receive usual medical care
Primary Outcome Measure Information:
Title
Primary Hierarchical Composite Endpoint
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Up to 30 days
Title
Seven-category Ordinal Scale
Description
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.
Time Frame
At 15 days
Title
Secondary Hierarchical Composite Endpoint
Description
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).
Time Frame
Up to 30 days
Other Pre-specified Outcome Measures:
Title
All-Cause Death
Description
Death from any cause during the observation period
Time Frame
Up to 30 days
Title
Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization
Description
Number of days that participants were alive and out of the hospital during the 30 days following randomization
Time Frame
Up to 30 days
Title
Exploratory Hierarchical Composite Endpoint
Description
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.
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not making it available
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