Trial Outcomes & Findings for Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate (NCT NCT05080192)

NCT ID: NCT05080192

Last Updated: 2024-06-21

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 12 participants
• Primary outcome timeframe: At baseline visit
• Results posted on: 2024-06-21

Participant Flow

Participant milestones

Measure	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)	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
Overall Study STARTED	7	5
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fenofibrate Recipients n=7 Participants 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)	Placebo Recipients n=5 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	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	54.29 years STANDARD_DEVIATION 10.64 • n=5 Participants	40.2 years STANDARD_DEVIATION 5.93 • n=7 Participants	48.42 years STANDARD_DEVIATION 11.28 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline visit

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

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

Outcome measures

Measure	Fenofibrate Recipients n=5 Participants 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)	Placebo Recipients n=5 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
Flow Mediated Dilation of the Brachial Artery	6.1 % of brachial artery dilation Interval 5.6 to 8.5	6.2 % of brachial artery dilation Interval 5.0 to 10.6

PRIMARY outcome

Timeframe: At baseline visit

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

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

Outcome measures

Measure	Fenofibrate Recipients n=6 Participants 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)	Placebo Recipients n=4 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
Arterial Wave Reflection Magnitude	43.7 % of forward wave amplitude Interval 37.9 to 51.8	42.9 % of forward wave amplitude Interval 32.8 to 47.2

PRIMARY outcome

Timeframe: At baseline visit

Population: 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.

Carotid-femoral pulse wave velocity measured with arterial tonometry

Outcome measures

Measure	Fenofibrate Recipients n=6 Participants 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)	Placebo Recipients n=4 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
Large Artery Stiffness	5.8 m/s Interval 5.5 to 6.6	7 m/s Interval 5.4 to 8.4

PRIMARY outcome

Timeframe: At baseline visit

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

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.

Outcome measures

Measure	Fenofibrate Recipients n=6 Participants 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)	Placebo Recipients n=4 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
Myocardial Function	-14.1 % change in length Interval -14.6 to -11.4	-17.9 % change in length Interval -18.8 to -17.4

PRIMARY outcome

Timeframe: At baseline visit

Population: The data for 2 participants (1 fenofibrate recipient and 1 placebo recipient) were omitted from analysis due to poor quality.

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

Outcome measures

Measure	Fenofibrate Recipients n=6 Participants 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)	Placebo Recipients n=4 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
Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)	23.3 mL/min/mmHg Interval 14.9 to 32.8	24 mL/min/mmHg Interval 19.5 to 32.1

PRIMARY outcome

Timeframe: At baseline visit

Population: 5 participants (2 fenofibrate recipients and 3 placebo recipients) did not undergo the test.

Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.

Outcome measures

Measure	Fenofibrate Recipients n=5 Participants 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)	Placebo Recipients n=2 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
Aerobic Capacity	12.1 mL/min/kg Interval 8.4 to 16.5	11.8 mL/min/kg Interval 10.0 to 13.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Fenofibrate Recipients n=7 Participants 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)	Placebo Recipients n=5 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
Self-reported Quality of Life Via Survey	75.7 score on a scale Interval 22.1 to 87.8	79.7 score on a scale Interval 74.5 to 81.5

Adverse Events

Fenofibrate Recipients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Recipients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fenofibrate Recipients n=7 participants at risk 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)	Placebo Recipients n=5 participants at risk 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
Skin and subcutaneous tissue disorders Skin irritation	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.
General disorders Arm numbness	0.00% 0/7 • 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.	20.0% 1/5 • Number of events 1 • 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.

Additional Information

Seavmeiyin Kun

University of Pennsylvania

Phone: 215-917-0115

Email: seavmeiyin.kun@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place