Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-25 @ 6:51 PM
Study NCT ID:
NCT05080192
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seavmeiyin.kun@pennmedicine.upenn.edu', 'phone': '215-917-0115', 'title': 'Seavmeiyin Kun', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The sample size of the study is too small (N=12) and there is not sufficient power to infer differences between the groups.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'description': 'Total number at risk is the total number of participants enrolled.', 'eventGroups': [{'id': 'EG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow Mediated Dilation of the Brachial Artery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '8.5'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '10.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': 'Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function', 'unitOfMeasure': '% of brachial artery dilation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 fenofibrate recipient did not undergo the test.'}, {'type': 'PRIMARY', 'title': 'Arterial Wave Reflection Magnitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '51.8'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '47.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': 'Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis', 'unitOfMeasure': '% of forward wave amplitude', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test.'}, {'type': 'PRIMARY', 'title': 'Large Artery Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.6'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '8.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': 'Carotid-femoral pulse wave velocity measured with arterial tonometry', 'unitOfMeasure': 'm/s', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Myocardial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.1', 'groupId': 'OG000', 'lowerLimit': '-14.6', 'upperLimit': '-11.4'}, {'value': '-17.9', 'groupId': 'OG001', 'lowerLimit': '-18.8', 'upperLimit': '-17.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': '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.', 'unitOfMeasure': '% change in length', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 placebo recipient did not undergo the test.'}, {'type': 'PRIMARY', 'title': 'Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '32.8'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '32.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': 'Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing', 'unitOfMeasure': 'mL/min/mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for 2 participants (1 fenofibrate recipient and 1 placebo recipient) were omitted from analysis due to poor quality.'}, {'type': 'PRIMARY', 'title': 'Aerobic Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '16.5'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '13.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': 'Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants (2 fenofibrate recipients and 3 placebo recipients) did not undergo the test.'}, {'type': 'PRIMARY', 'title': 'Self-reported Quality of Life Via Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'OG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '87.8'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '81.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline visit', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'FG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fenofibrate Recipients', 'description': 'Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nFenofibrate: 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)'}, {'id': 'BG001', 'title': 'Placebo Recipients', 'description': 'Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.\n\nPlacebo: Matching placebo (once/day) for 10 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.29', 'spread': '10.64', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '5.93', 'groupId': 'BG001'}, {'value': '48.42', 'spread': '11.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-08', 'size': 1671179, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-20T15:49', 'hasProtocol': True}, {'date': '2023-11-01', 'size': 540465, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-20T15:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, urine, breath condensate, buffy coat, endothelial cells and RNA will be collected from study subjects'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2021-08-17', 'resultsFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-18', 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow Mediated Dilation of the Brachial Artery', 'timeFrame': 'At baseline visit', 'description': 'Flow Mediated dilation of the brachial artery measured with ultrasound. This is a metric of endothelial function'}, {'measure': 'Arterial Wave Reflection Magnitude', 'timeFrame': 'At baseline visit', 'description': 'Arterial wave reflection magnitude measured with high fidelity arterial tonometry and wave separation analysis'}, {'measure': 'Large Artery Stiffness', 'timeFrame': 'At baseline visit', 'description': 'Carotid-femoral pulse wave velocity measured with arterial tonometry'}, {'measure': 'Myocardial Function', 'timeFrame': 'At baseline visit', 'description': '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.'}, {'measure': 'Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)', 'timeFrame': 'At baseline visit', 'description': 'Diffusion capacity of lungs for carbon monoxide (DLCO) measured during pulmonary function testing'}, {'measure': 'Aerobic Capacity', 'timeFrame': 'At baseline visit', 'description': 'Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.'}, {'measure': 'Self-reported Quality of Life Via Survey', 'timeFrame': 'At baseline visit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 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).\n\nExclusion Criteria\n\n* Prisoners/incarcerated individuals;\n* 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\n* Inability to provide informed consent.\n* 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.\n* Estimated glomerular filtration rate \\<30 mL/min/1.73m2 prior to the index COVID-19 episode.'}, 'identificationModule': {'nctId': 'NCT05080192', 'briefTitle': 'Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 - Effect of Fenofibrate', 'orgStudyIdInfo': {'id': '844349'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fenofibrate recipients', 'description': 'Approximately 20 subjects who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization.', 'interventionNames': ['Drug: Fenofibrate']}, {'label': 'Placebo recipients', 'description': 'Approximately 20 subjects who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fenofibrate', 'type': 'DRUG', 'otherNames': ['Tricor'], 'description': '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)', 'armGroupLabels': ['Fenofibrate recipients']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo (once/day) for 10 days', 'armGroupLabels': ['Placebo recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}