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

NCT05080192 | Completed Results

• 1 other identifier: 844349
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (7)

• Flow Mediated Dilation of the Brachial Artery

  Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function

  At baseline visit

• Arterial Wave Reflection Magnitude

  Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis

  At baseline visit

• Large Artery Stiffness

  Carotid-femoral pulse wave velocity measured with arterial tonometry

  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.

  At baseline visit

• Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)

  Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing

  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.

  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.

  At baseline visit

Study Arms (2)

Fenofibrate recipients

Approximately 20 subjects who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.

Drug: Fenofibrate

Placebo recipients

Approximately 20 subjects who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.

Drug: Placebo

Interventions

Fenofibrate DRUG

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)

Also known as: Tricor

Fenofibrate recipients

Placebo DRUG

Matching placebo (once/day) for 10 days

Placebo recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be screened from our FERMIN trial population. Participants will be approached by a member of the study team for participation. Participants will undergo a comprehensive assessment of key phenotypes (6±3 months after the index COVID-19 episode).

You may qualify if:

• 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).

You may not qualify if:

• Prisoners/incarcerated individuals;
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, urine, breath condensate, buffy coat, endothelial cells and RNA will be collected from study subjects

MeSH Terms

Conditions

COVID-19

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Limitations and Caveats

The sample size of the study is too small (N=12) and there is not sufficient power to infer differences between the groups.

Results Point of Contact

• Title: Seavmeiyin Kun
• Organization: University of Pennsylvania

seavmeiyin.kun@pennmedicine.upenn.edu

215-917-0115

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: October 15, 2021
• Study Start: August 11, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-06

Locations

US (1)