Clinical trial

Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 - Effect of Fenofibrate

Name

844349

Description

The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The trial is testing a short intervention (10 days of fenofibrate therapy) on 30-day outcomes in COVID-19. The overarching goal of this sub-study is to explore the impact of fenofibrate on key longer term phenotypes of vascular, cardiac and pulmonary health, integrated cardiopulmonary function, persistent/chronic symptoms and quality of life.

Trial arms

Trial start

2021-08-11

Estimated PCD

2022-05-10

Trial end

2022-05-10

Status

Completed

Treatment

Fenofibrate

145 mg/d of Tricor (administered as part of the parent FERMIN trial) for 10 days, or renal corrected dose equivalent (depending on renal function)

Arms:

Fenofibrate recipients

Other names:

Tricor

Placebo

Matching placebo (once/day) for 10 days

Arms:

Placebo recipients

Size

Primary endpoint

Flow Mediated Dilation of the Brachial Artery

At baseline visit

Arterial Wave Reflection Magnitude

At baseline visit

Large Artery Stiffness

At baseline visit

Myocardial Function

At baseline visit

Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)

At baseline visit

Aerobic Capacity

At baseline visit

Self-reported Quality of Life Via Survey

At baseline visit

Eligibility criteria

Inclusion Criteria: • Having been eligible, enrolled and randomized in the parent FERMIN trial, completing all study procedures up to the 30-day time point (as specified in the parent protocol). Exclusion Criteria * Prisoners/incarcerated individuals; * Pregnancy (potentially eligible patients of reproductive age will undergo a pregnancy test). This exclusion is due to the fact that pregnancy may confound the various cardiopulmonary phenotypes assessed in this study * Inability to provide informed consent. * History of cardiovascular disease (defined as heart failure, myocardial infarction, coronary revascularization, serious arrhythmia, stroke, or peripheral artery disease), glomerular disease or polycystic kidney disease prior to the index COVID-19 episode. * Estimated glomerular filtration rate \<30 mL/min/1.73m2 prior to the index COVID-19 episode.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, urine, breath condensate, buffy coat, endothelial cells and RNA will be collected from study subjects'}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2024-06-21

1 organization

1 product

1 drug

1 indication

Organization

University of Pennsylvania

Product

Fenofibrate

Indication

COVID-19

Drug

Varlilumab