Fenofibrate for coronavirus disease

Fenofibrate as a Metabolic Intervention for Coronavirus Disease 2019 (COVID-19): A randomized controlled trial (FERMIN trial)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000843-33-GR

Enrollment

200

Registered

2021-03-11

Start date

2021-04-23

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease-19 MedDRA version: 24.1 Level: PT Classification code 10084381 Term: Coronavirus pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: LLT Classification code 10084529 Term: 2019 novel coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Lipidil Product Name: Fenofibrate Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age 18 years or older (2) 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, interstitial or ground glass opacities) or chest CT. (3) Able to provide informed consent. (4) Fewer than 14 days since symptom onset. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: (1) Known pregnancy or breastfeeding. (2) Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2 or undergoing dialysis (CKD stages 4-5). (3) 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. (4) Known hypersensitivity to fenofibrate or fenofibric acid. (5) Ongoing treatment with fenofibrate, clofibrate, warfarin and other coumarin anticoagulants, glimepiride, cyclosporine, tacrolimus. (6) Use of statins other than simvastatin, pravastatin or atorvastatin =40 mg/d or rosuvastatin =20 mg/d. (7) Prisoners/incarcerated individuals (8) Intubated patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: The clinical impact of fenofibrate to improve clinical outcomes in patients with COVID-19. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to 5 factors: (1) time to death (ranked from shortest to longest, up to 30 days post-randomization), (2) the number of days supported by mechanical ventilation (invasive or non-invasive) or extracorporeal membrane oxygenation (until hospital discharge, up to 30 days post-randomization, ranked from longest to shortest); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve (until hospital discharge, up to 30 days post-randomization, ranked from highest to lowest); (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 (ranked from lowest to highest); (5) For participants enrolled as outpatients who don’t get hospitalized during the 30-day observation period, the modified Borg dyspnea scale (mean value of assessments at ~5, ~10 and ~15 days). Patients who are enrolled as inpatients but discharged within 24 hours of receiving the first dose of the study medication will be ranked similarly to outpatients.;Timepoint(s) of evaluation of this end point: Day 30	—

Measure

Time frame

Main Objective: The clinical impact of fenofibrate to improve clinical outcomes in patients with COVID-19. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to 5 factors: (1) time to death (ranked from shortest to longest, up to 30 days post-randomization), (2) the number of days supported by mechanical ventilation (invasive or non-invasive) or extracorporeal membrane oxygenation (until hospital discharge, up to 30 days post-randomization, ranked from longest to shortest); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve (until hospital discharge, up to 30 days post-randomization, ranked from highest to lowest); (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 (ranked from lowest to highest); (5) For participants enrolled as outpatients who don’t get hospitalized during the 30-day observation period, the modified Borg dyspnea scale (mean value of assessments at ~5, ~10 and ~15 days). Patients who are enrolled as inpatients but discharged within 24 hours of receiving the first dose of the study medication will be ranked similarly to outpatients.;Timepoint(s) of evaluation of this end point: Day 30

—

Secondary

Measure	Time frame
Secondary end point(s): (1) Number of days alive, out of the intensive care unit, free of mechanical ventilation (invasive and non-invasive), extracorporeal membrane oxygenation (ECMO) or maximal available respiratory support in the 30 days following randomization. (2) 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) A global rank score similar to the primary endpoint, but using a more comprehensive COVID-19 symptom scale instead of the dyspnea Borg scale ;Timepoint(s) of evaluation of this end point: Day 30	—

Measure

Time frame

Secondary end point(s): (1) Number of days alive, out of the intensive care unit, free of mechanical ventilation (invasive and non-invasive), extracorporeal membrane oxygenation (ECMO) or maximal available respiratory support in the 30 days following randomization. (2) 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) A global rank score similar to the primary endpoint, but using a more comprehensive COVID-19 symptom scale instead of the dyspnea Borg scale ;Timepoint(s) of evaluation of this end point: Day 30

—

Countries

Greece

Contacts

Public ContactPresident of the Board

Hellenic Institute for the Study of Sepsis

insepsis@otenet.gr00302107480662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026