CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 701 enrolled
Drug / intervention
Fenofibrate/fenofibric acid +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04517396
NCT04517396Phase 2Completed

FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019

University of Pennsylvania·interventional·Posted Aug 18, 2020·Updated Mar 24, 2023

In Brief

A Phase 2 clinical trial evaluating Fenofibrate/fenofibric acid, Placebo, and 1 other intervention for Covid19. Completed, enrolled 701 participants across 1 site.

Detailed Summary

The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease (\[CKD\]) to improve clinical outcomes in patients with COVID-19.

Study Details

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 18, 2020
Enrollment StartAug 18, 2020
Primary CompletionMar 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.9 years ago

Interventions

Fenofibrate/fenofibric acidother

The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days.

Placeboother

The control intervention will be a placebo, for 10 days.

Usual careother

All participants will otherwise receive usual medical care