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IRCT20220612055149N1 IRCT 2022-07-24 Artesh University of Medical Sciences Evaluation of efficacy and safety of Fenofibrate in COVID-19 patients A clinical trial comparing the effect of Fenofibrate on the prognosis in hospitalized patients with COVID-19 2021-05-05 anticipated 70 Complete https://irct.ir/trial/64128 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method was applied for the current study to determine the study group for each patient (intervention or placebo). Therefore, numbers from 1 to 70 were grouped as intervention or placebo using random allocation. After the patients were enrolled, they were allocated to one of the two study groups using the table of numbers starting from 1, Blinding description: Patients, the physician, and the outcome assessor were blind as to which study group the patient was allocated. Placebo had similar appearance characteristics including odor and color as the study medication in the intervention group. Placebo and the drug were grouped as A and B as neither the distributor nor the patient knew the labeling information. 3 COVID-19. Intervention 1: Intervention group: Patients admitted following COVID-19 receive 200 milligrams of Fenofibrate capsule by Sobhan Darou including one 100 milligram capsule every 12 hours orally during hospitalization days for a maximum period of 14 days. In both study groups, patients receive further similar treatments according to the national guideline for the standard of care in COVID-19. Intervention 2: Control group: Patients receive an oral placebo by Sobhan Darou every 12 hours. Also, patients receive standard of care treatments as recommended by the national COVID-19 committee and in line with national guidelines similar to those in the intervention group. Yes - There is a plan to make this available What will be shared: Data regarding clinical outcomes and those variables of clinical importance will be potentially published through a scientific article after making personal data of our patients undetectable. When: Access date is based on an agreement with the publisher of the scientific article probably after print for a period of 2 years To whom: Faculty of medical universities Conditions: Research purposes Where to obtain: Email of the corresponding author: Syrous.faraji@yahoo.com How to obtain: An email to the corresponding author Comments:
public Farbod Hatami
Cardiovascular Diseases Research Center, Razi hospitaŁ…, Ghaffari St.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3162 6459 f.hatami@bums.ac.ir Birjand University of Medical Sciences scientific Sirus Faraji
Shahid Etemadzadeh St., West Fatemi St.
Tehran Iran (Islamic Republic of) 1781997511 +98 21 8609 6350 Sirus.faraji@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years Confirmed diagnosis of COVID-19 with RT-PCR Hospitalization Symptom onset lower than 10 days 18 years no limit Both Pregnancy, breastfeeding Known hypersensitivity to fibrate agents History of Fenofibrate treatment Previous treatment with warfarin, ciclosporin, tacrolimus, and atorvastatin more than 40 milligrams (mg) daily History of liver diseases, and hypothyroidism U07.1 COVID-19 Treatment - Drugs Placebo Intervention group: Patients admitted following COVID-19 receive 200 milligrams of Fenofibrate capsule by Sobhan Darou including one 100 milligram capsule every 12 hours orally during hospitalization days for a maximum period of 14 days. In both study groups, patients receive further similar treatments according to the national guideline for the standard of care in COVID-19. Control group: Patients receive an oral placebo by Sobhan Darou every 12 hours. Also, patients receive standard of care treatments as recommended by the national COVID-19 committee and in line with national guidelines similar to those in the intervention group. Mortality. Timepoint: From admission to 3 months after discharge. Method of measurement: Electronic records and contacting patient after discharge. ICU admission. Timepoint: From hospitalization to discharge. Method of measurement: Patient status by electronic records. Hospitalization days. Timepoint: At discharge. Method of measurement: Patient electronic records. ICU stay. Timepoint: At dischagre. Method of measurement: Patient electronic records. Mechanical ventilaton. Timepoint: At discharge. Method of measurement: Need for mechanical ventilation by reviewing electronic records. Artesh University of Medical Sciences Approved 2021-02-17 Research Ethics Committees of AJA University of Medical Sciences West Fatemi St., Shahid Etemadzadeh St. Tehran Tehran Iran (Islamic Republic of)