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UNKNOWNPHASE3

Fenofibrate for Patients With COVID-19 Requiring Hospitalization

A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization

NCT04661930•Yaakov Nahmias

View on ClinicalTrials.gov

Summary

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.

Detailed Description

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission. Open-label patients will be matched at least 1:10 with observational retrospective Propensity score-matched (PSM) patients' medical files. The double-blinded step will be randomized 2:1 to daily Fenofibrate or placebo for 10 days or hospital discharge.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Presumptive positive laboratory test for SARS-CoV-2 based on local laboratory standard
•Age greater than or equal to 18 years of age
•Severe COVID-19, defined by:
•* A disease severity score of 3 (Hospitalized, on non-invasive ventilation or high flow oxygen devices) to 4 (Hospitalized, requiring supplemental oxygen).
•AND o A respiratory SOFA \>=1 and increased oxygen requirement compared to baseline among those on home O2, a blood oxygen saturation of 93% or less on room air, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) of less than 300 mm Hg, respiratory rate \>30 breaths/min, or lung infiltrates \>50% on chest CT
•Enrollment within 72 hours of presentation of hospital admission or within 72 hours of a positive test result, whichever is later

Exclusion Criteria

•Enrollment \> 72 hours of admission order or positive test result, whichever is later
•Admission to the hospital with a respiratory SOFA \>=5 , Critical COVID-19, or Disease Severity Score \>5 (requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or all)
•Known hypersensitivity to fenofibrate
•For female subjects:
•1. Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kit or a blood test
•2. Breastfeeding
•3. Undergoing fertility treatments
•Patient-reported history or electronic medical record history of kidney disease, defined as:
•1. Any history of dialysis
•2. History of chronic kidney disease stage IV
+12 more criteria

Locations (3)

Barzilai Medical Center

Ashkelon, Israel

Rambam Health Care Campus

Haifa, Israel

Nazareth Hospital EMMS

Nazareth, Israel

Key Dates

Start Date

January 1, 2021

Primary Completion Date

May 1, 2022

Completion Date

July 1, 2022

Last Updated

April 19, 2022

Enrollment

ESTIMATED participants

Conditions

Corona Virus Disease (COVID-19)Respiratory Distress SyndromeSARS-CoV-2 Infection

Interventions

TriCor® 145mg tablets

DRUG

Placebo

OTHER

Usual care

OTHER

Contacts

Yaakov Nahmias, PhD

CONTACT

+972-2-5494640 ynahmias@cs.huji.ac.il

Avner Ehrlich

CONTACT

+972-54-3181422 avner.ehrlich@mail.huji.ac.il

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fenofibrate for Patients With COVID-19 Requiring Hospitalization

Inclusion Criteria

Exclusion Criteria

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