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.
The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The aim of this trial is to assess the impact of fenofibrate (administered for 10 days) to improve clinical outcomes in patients with COVID-19, assessed at 30 days. However, given the accumulating evidence of chronic / long term sequelae of COVID-19, it is important to assess the long-term impact of this intervention in this patient population. The overarching goal of this substudy is to assess the impact of fenofibrate on key intermediate phenotypes of vascular, cardiac and pulmonary health. We also aim to address the impact of fenofibrate therapy (administered during the acute COVID-19 episode as part of the parent FERMIN trial) on long-term integrated cardiopulmonary function, persistent/chronic symptoms and quality of life. We will accomplish this via enrollment of previous FERMIN participants from the University of Pennsylvania, in an phenotyping study designed to assess vascular, cardiac and pulmonary status several months after the index episode of COVID-19. We will perform these assessments \~6 months after initial randomization, among 40 FERMIN trial participants enrolled at the University of Pennsylvania.
Study Type
OBSERVATIONAL
Enrollment
12
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)
Matching placebo (once/day) for 10 days
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Flow Mediated Dilation of the Brachial Artery
Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function
Time frame: At baseline visit
Arterial Wave Reflection Magnitude
Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis
Time frame: At baseline visit
Large Artery Stiffness
Carotid-femoral pulse wave velocity measured with arterial tonometry
Time frame: At baseline visit
Myocardial Function
Peak longitudinal strain assessed with echocardiography. Longitudinal strain was measured as the shortening of the LV cavity longitudinal dimension (mitral annulus plane to apex) in apical echocardiographic views, expressed as the percent change relative to the end-diastolic length, where shortening is expressed as a negative change.
Time frame: At baseline visit
Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing
Time frame: At baseline visit
Aerobic Capacity
Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.
Time frame: At baseline visit
Self-reported Quality of Life Via Survey
Quality of life measured with the Kansas City Cardiomyopathy questionnaire (KCCQ). The overall summary score from the KCCQ ranges from 0-100, where higher scores indicate a better quality of life.
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Time frame: At baseline visit