Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT04859894
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011660', 'term': 'Pulmonary Heart Disease'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum Venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Oxygen Consumption (VO2peak)', 'timeFrame': 'At baseline', 'description': 'Cross-sectional evaluation of VO2peak and the association with symptoms'}], 'secondaryOutcomes': [{'measure': 'Peak Oxygen Consumption (VO2peak)', 'timeFrame': 'In subset of subjects at 1 year', 'description': 'Improvement in VO2peak over 1 year'}, {'measure': 'VE/VCO2-slope', 'timeFrame': 'At baseline, in subset at 1 year', 'description': 'Cross-sectional evaluation of VE/VCO2 and the association with symptoms'}, {'measure': 'Diffusion Capacity (DLCOc)', 'timeFrame': 'At baseline, in subset at 1 year', 'description': 'Cross-sectional evaluation of DLCOc and the association with symptoms'}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': 'At baseline, in subset at 1 year', 'description': 'Cross-sectional evaluation of FEV1 and the association with symptoms'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'At baseline, in subset at 1 year', 'description': 'Cross-sectional evaluation of FVC and the association with symptoms'}, {'measure': 'Total Lung Capacity (TLC)', 'timeFrame': 'At baseline, in subset at 1 year', 'description': 'Cross-sectional evaluation of TLC and the association with symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Exercise Testing', 'Lung Function Testing', 'Echocardiography', 'DNA-methylation', 'Covid19'], 'conditions': ['Covid19', 'Cardiopulmonary Disease', 'Dyspnea', 'Lung Function Decreased', 'Epigenetic Disorder']}, 'descriptionModule': {'briefSummary': "The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values. In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.", 'detailedDescription': "The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.\n\nThis study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.\n\nIn addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects fulfilling inclusion criteria and no exclusion criterion referred for a clinical examination at the specified clinic will be informed about the study and inquired regarding participation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed or clinically highly suspected Covid19-infection\n* Symptom duration at least 12 weeks following first occurence of symptoms\n* No other disease that better could explain the symptoms than Covid19\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Unability to perform a maximal exercise test\n* Unability to understand written or spoken Swedish'}, 'identificationModule': {'nctId': 'NCT04859894', 'briefTitle': 'Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation', 'orgStudyIdInfo': {'id': '2021-01620'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid19', 'description': 'Patients aged \\>18 years with confirmed Covid19 disease with symptoms \\>12 weeks, not better explained by other disease', 'interventionNames': ['Diagnostic Test: Physiological testing']}], 'interventions': [{'name': 'Physiological testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing.', 'armGroupLabels': ['Covid19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58737', 'city': 'Linköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Kristofer Hedman, MD, PhD', 'role': 'CONTACT', 'email': 'kristofer.hedman@liu.se', 'phone': '+46704897941'}], 'facility': 'Dept Health, Medicine and Caring Sciences', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'As part of a national collaboration on Post Covid19, coded (deidentified) data may be shared with other selected researchers in accordance with the ethical permission obtained by the Ethical Review Board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kristofer Hedman', 'investigatorAffiliation': 'Linkoeping University'}}}}