Covid19NCT05080192

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

An observational study of Covid19, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Fenofibrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 11 Aug 2021to 10 May 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Conditions: Covid19
Being tested: Fenofibrate, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FenofibrateDrug
Also called Tricor
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)
PlaceboDrug
Matching placebo (once/day) for 10 days

Study groups in NCT05080192
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Flow Mediated Dilation of the Brachial Artery
Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function
Measured: At baseline visit
Arterial Wave Reflection Magnitude
Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis
Measured: At baseline visit
Large Artery Stiffness
Carotid-femoral pulse wave velocity measured with arterial tonometry
Measured: 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.
Measured: At baseline visit
Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing
Measured: 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.
Measured: 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.
Measured: At baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202110 May 2022

First posted15 Oct 2021
Study start11 Aug 2021
Primary completion10 May 2022
Study completion10 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05080192
Sponsor's protocol ID: 844349
Status last verified: Jun 2024
First submitted: 17 Aug 2021
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 - Effect of Fenofibrate
ClinicalTrials.gov ID: NCT05080192
Acronym / sponsor ID: 844349
Conditions: Covid19
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 11 Aug 2021 (actual)
Primary completion: 10 May 2022 (actual)
Study completion: 10 May 2022 (actual)
First posted: 15 Oct 2021 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Fenofibrate recipients	–	Drug: FenofibrateApproximately 20 subjects who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.
Placebo recipients	–	Drug: PlaceboApproximately 20 subjects who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FenofibrateAlso: Tricor145 mg/d of Tricor (administered as part of the parent FERMIN trial) for 10 days, or renal corrected dose equivalent (depending on renal function)	Drug	Fenofibrate recipients
PlaceboMatching placebo (once/day) for 10 days	Drug	Placebo recipients

Primary outcome

Flow Mediated Dilation of the Brachial Artery
Time frame: At baseline visit
Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function
Arterial Wave Reflection Magnitude
Time frame: At baseline visit
Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis
Large Artery Stiffness
Time frame: At baseline visit
Carotid-femoral pulse wave velocity measured with arterial tonometry
Myocardial Function
Time frame: At baseline visit
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.
Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)
Time frame: At baseline visit
Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing
Aerobic Capacity
Time frame: At baseline visit
Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.
Self-reported Quality of Life Via Survey
Time frame: At baseline visit
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.

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fenofibrate Recipients	7	7
Placebo Recipients	5	5

Primary outcome: Flow Mediated Dilation of the Brachial Artery

Time frame: At baseline visit. Median (Inter-Quartile Range). Unit: % of brachial artery dilation

Measure	Fenofibrate Recipients n = 5	Placebo Recipients n = 5
Value	6.1 (5.6 to 8.5)	6.2 (5.0 to 10.6)

Population analysed: The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 fenofibrate recipient did not undergo the test.

Primary outcome: Arterial Wave Reflection Magnitude

Time frame: At baseline visit. Median (Inter-Quartile Range). Unit: % of forward wave amplitude

Measure	Fenofibrate Recipients n = 6	Placebo Recipients n = 4
Value	43.7 (37.9 to 51.8)	42.9 (32.8 to 47.2)

Population analysed: The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test.

Primary outcome: Large Artery Stiffness

Time frame: At baseline visit. Median (Inter-Quartile Range). Unit: m/s

Measure	Fenofibrate Recipients n = 6	Placebo Recipients n = 4
Value	5.8 (5.5 to 6.6)	7 (5.4 to 8.4)

Population analysed: The data for 1 fenofibrate recipient was omitted due to poor quality. The data for 1 placebo recipient was not collected due to technical difficulty.

Primary outcome: Myocardial Function

Time frame: At baseline visit. Median (Inter-Quartile Range). Unit: % change in length

Measure	Fenofibrate Recipients n = 6	Placebo Recipients n = 4
Value	-14.1 (-14.6 to -11.4)	-17.9 (-18.8 to -17.4)

Population analysed: The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test.

Adverse events

Time frame: Adverse events were collected for each participant starting on their baseline visit, during 24-hour ambulatory blood pressure monitoring, and at bike test, up to 3 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fenofibrate Recipients	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Placebo Recipients	0 of 5 (0%)	1 of 5 (20%)	0 of 5

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow Mediated Dilation of the Brachial Artery (time frame: At baseline visit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.