Fenofibrate for coronavirus disease

Phase 1

• Conditions: Coronavirus disease-19; MedDRA version: 23.0Level: LLTClassification code 10084381Term: Coronavirus pneumoniaSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862; MedDRA version: 23.1Level: LLTClassification code 10084529Term: 2019 novel coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000843-33-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-11
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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

(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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified