Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 1:58 PM
Study NCT ID:
NCT04903132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular Senescence and COVID-19 Long-Hauler Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors', 'timeFrame': '6 months', 'description': 'If a correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors can be demonstrated, or SASP factors are higher in Long-Hauler Syndrome clinic patients than age- and sex-matched controls (using archived samples) in this pilot study, a protocol will be submitted to the IRB for a trial in Long-Hauler Syndrome patients of senolytic drugs.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV2 Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Longhauler's Cohort: Patients must be at least 18 years or older, have a positive PCR or antibody test within six months, and report any ongoing symptoms associated with Post-COVID or Long-Haulers Syndrome.\n\nControl Cohort: Patients must be at least 18 years or older, have not had a known case of COVID-19 or Longhauler's syndrome.\n\nCOVID Control Cohort: Patients must be at least 18 years or older and have had COVID-19 but no known Longhauler's syndrome.", 'healthyVolunteers': True, 'eligibilityCriteria': "Longhauler's Cohort -\n\nInclusion Criteria:\n\n* Ability to give informed consent or LAR.\n* At least 18 years old.\n* Ability of subject or LAR to read and speak the English language.\n* Positive PCR or antibody test within 12 months of initial study visit.\n* Patient of the Long-Hauler Syndrome clinic and differential diagnosis of Long-Hauler Syndrome.\n\nExclusion Criteria:\n\n* Any potential participant who refuses medical record review.\n* Pregnant females.\n* Incarcerated individuals.\n* Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.\n\nControl Cohort -\n\nInclusion Criteria:\n\n* Ability to give informed consent\n* At least 18 years old\n* Ability of subject to read and speak the English language\n\nExclusion Criteria:\n\n* Known case of COVID-19.\n* Any potential participant who refuses medical record review.\n* Pregnant females.\n* Incarcerated individuals.\n* Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.\n\nCOVID-19 Control Cohort\n\nInclusion Criteria:\n\n* Ability to give informed consent.\n* At least 18 years old.\n* Ability of subject to read and speak the English language.\n* Known case of COVID-19.\n\nExclusion Criteria:\n\n* Known Longhauler's syndrome/Post-COVID\n* Any potential participant who refuses medical record review.\n* Pregnant females.\n* Incarcerated individuals.\n* Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study."}, 'identificationModule': {'nctId': 'NCT04903132', 'briefTitle': 'Cellular Senescence and COVID-19 Long-Hauler Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Cellular Senescence and Its Contribution to COVID-19 Long-Hauler Syndrome', 'orgStudyIdInfo': {'id': '20-011877'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Longhauler's Syndrome Cohort", 'description': "Subject's with longhaulers"}, {'label': 'Control Cohort', 'description': "Control cohort will not have had a known case of COVID-19 or Longhauler's syndrome"}, {'label': 'COVID Control Cohort', 'description': "Subjects who have had COVID-19 but no known Longhauler's syndrome"}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ryan T. Hurt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ryan T. Hurt, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}