N/A
N=12
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT05080192 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Flow Mediated Dilation of the Brachial Artery — 6.1; 6.2 % of brachial artery dilation
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fenofibrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation of the Brachial Artery |
6.1; 6.2 | — |
| PRIMARY Arterial Wave Reflection Magnitude |
43.7; 42.9 | — |
| PRIMARY Large Artery Stiffness |
5.8; 7 | — |
| PRIMARY Myocardial Function |
-14.1; -17.9 | — |
| PRIMARY Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) |
23.3; 24 | — |
| PRIMARY Aerobic Capacity |
12.1; 11.8 | — |
| PRIMARY Self-reported Quality of Life Via Survey |
75.7; 79.7 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT05080192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.