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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fenofibrate Recipients | Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization. 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) |
| FG001 | Placebo Recipients | Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Placebo: Matching placebo (once/day) for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fenofibrate Recipients | Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization. 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flow Mediated Dilation of the Brachial Artery | Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function | The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 fenofibrate recipient did not undergo the test. | Posted | Median | Inter-Quartile Range | % of brachial artery dilation | At baseline visit |
|
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.
Total number at risk is the total number of participants enrolled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fenofibrate Recipients | Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization. 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
The sample size of the study is too small (N=12) and there is not sufficient power to infer differences between the groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seavmeiyin Kun | University of Pennsylvania | 215-917-0115 | seavmeiyin.kun@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2023 | Nov 20, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2023 | Nov 20, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Plasma, urine, breath condensate, buffy coat, endothelial cells and RNA will be collected from study subjects
|
| Placebo | Drug | Matching placebo (once/day) for 10 days |
|
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 |
| Placebo Recipients |
Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Placebo: Matching placebo (once/day) for 10 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Placebo: Matching placebo (once/day) for 10 days |
|
|
| Primary | Arterial Wave Reflection Magnitude | Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis | The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test. | Posted | Median | Inter-Quartile Range | % of forward wave amplitude | At baseline visit |
|
|
|
| Primary | Large Artery Stiffness | Carotid-femoral pulse wave velocity measured with arterial tonometry | 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. | Posted | Median | Inter-Quartile Range | m/s | At baseline visit |
|
|
|
| Primary | 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. | The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test. | Posted | Median | Inter-Quartile Range | % change in length | At baseline visit |
|
|
|
| Primary | Diffusion Capacity of Lungs for Carbon Monoxide (DLCO) | Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing | The data for 2 participants (1 fenofibrate recipient and 1 placebo recipient) were omitted from analysis due to poor quality. | Posted | Median | Inter-Quartile Range | mL/min/mmHg | At baseline visit |
|
|
|
| Primary | Aerobic Capacity | Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis. | 5 participants (2 fenofibrate recipients and 3 placebo recipients) did not undergo the test. | Posted | Median | Inter-Quartile Range | mL/min/kg | At baseline visit |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At baseline visit |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Placebo Recipients | Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Placebo: Matching placebo (once/day) for 10 days | 0 | 5 | 0 | 5 | 1 | 5 |
| Arm numbness | General disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |