FEnofibRate as a Metabolic INtervention for COVID-19

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.

Conditions

• Covid19

Interventions

OTHER

Fenofibrate/fenofibric acid

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.

OTHER

Placebo

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

OTHER

Usual care

All participants will otherwise receive usual medical care

Sponsors & Collaborators

• University of Arizona

  collaborator OTHER

• Universidad Católica de Santa María

  collaborator OTHER

• Hospital Nacional Adolfo Guevara Velasco

  collaborator OTHER

• Hospital Nacional Edgardo Rebagliati Martins

  collaborator OTHER

• Hospital Nacional Alberto Sabogal Sologuren

  collaborator OTHER

• Hospital Nacional Guillermo Almenara Irigoyen

  collaborator OTHER

• Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud

  collaborator OTHER

• Universidad de Santander

  collaborator OTHER

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Hospital Civil de Guadalajara

  collaborator OTHER

• Hospital Nacional Dos De Mayo

  collaborator OTHER

• Hospital Central Fuerza Aérea del Perú

  collaborator OTHER

• Hospital Militar Central.Coronel Luis Arias Schereiber

  collaborator OTHER

• Hospital Victor Lazarte Echegaray

  collaborator OTHER

• University Hospital, Ioannina

  collaborator OTHER

• AHEPA University Hospital

  collaborator OTHER

• Sotiria Thoracic Diseases Hospital of Athens

  collaborator OTHER

• Thriasio General Hospital of Elefsina

  collaborator OTHER

• University Hospital, Alexandroupolis

  collaborator OTHER

• G.Gennimatas General Hospital

  collaborator OTHER

• Biomelab S.A.S.

  collaborator INDUSTRY

• Fundación Oftalmológica de Santander. Santander, Colombia

  collaborator OTHER

• IPS Centro Científico Asistencial. Barranquilla, Colombia

  collaborator OTHER

• Fundación Cardiomet. Quindio, Colombia

  collaborator OTHER

• ClÍnica de Marly

  collaborator OTHER

• Clínica Internacional

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-18

Primary Completion

2022-03-30

Completion

2022-03-30

Countries

• United States

Study Locations