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

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 200 人开始时间: 2021年3月11日最近更新: 2021年10月18日

适应症

试验速览

暂无简介。

•(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

•(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.

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