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.
Drug: 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)
Other Name: Tricor
Drug: Placebo
Matching placebo (once/day) for 10 days
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.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Investigator: Julio A Chirinos, MD, PhD
Contact: 215-200-7779
julio.chirinos@pennmedicine.upenn.edu
Julio A Chirinos, MD, PhD
215-200-7779
julio.chirinos@pennmedicine.upenn.edu
Katherine Greene, MPH
215-662-7580
katherine.greene@pennmedicine.upenn.edu
Not Provided