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Trial - IRCT20220612055149N1


Column Value
Trial registration number IRCT20220612055149N1
Full text link
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mojtaba Yousefi Zoshk

Contact
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mojtaba.yousefi@gmail.com

Registration date
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-07-24

Recruitment status
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Age more than 18 years Confirmed diagnosis of COVID-19 with RT-PCR Hospitalization Symptom onset lower than 10 days

Exclusion criteria
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Artesh University of Medical Sciences

Inclusion age min
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

70

primary outcome
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mortality ICU admission

Notes
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : July 24, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 507, "treatment_name": "Fenofibrate", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]