Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT04793269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Long COVID-19 Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'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': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'once through study completion, an average of 6 months.', 'description': 'modified medical research council (scale from 0 to 4). The higher the score the worse the symptoms.'}, {'measure': 'self-addressed Quality of life', 'timeFrame': 'once through study completion, an average of 6 months', 'description': 'Short form health 36 questionnaire with 8 domains, each rated from 0-100. The higher the score the better subjective quality of life.'}, {'measure': 'Thoracic pain', 'timeFrame': 'once through study completion, an average of 6 months', 'description': 'assessed by medical interview (reported as yes or no)'}, {'measure': 'Medical history', 'timeFrame': 'once through study completion, an average of 6 months', 'description': 'List of relevant morbidities assessed as present/not present by medical interview (e.g. respiratory, cardial, neurological, psychiatric diseases by interview and medical records)'}, {'measure': 'Fibrosis', 'timeFrame': 'once through study completion, an average of 6 months', 'description': 'Assessed by chest CT, rated as present/not present'}, {'measure': 'Myocardial damage', 'timeFrame': 'once through study completion, an average of 6 months', 'description': 'Assessed by myocardial damage, rated as present/not present'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long COVID', 'post COVID'], 'conditions': ['Long COVID Syndrome']}, 'referencesModule': {'references': [{'pmid': '37173355', 'type': 'DERIVED', 'citation': 'Malesevic S, Sievi NA, Baumgartner P, Roser K, Sommer G, Schmidt D, Vallelian F, Jelcic I, Clarenbach CF, Kohler M. Impaired health-related quality of life in long-COVID syndrome after mild to moderate COVID-19. Sci Rep. 2023 May 12;13(1):7717. doi: 10.1038/s41598-023-34678-8.'}]}, 'descriptionModule': {'briefSummary': 'Characterization of patients with long COVID syndrome including symptoms, medical history and persistent organ damage.', 'detailedDescription': 'Some people are very hesitant to recover from a COVID-19 infection and present persistent symptoms. The participants still suffer after the acute phase of the infection from shortness of breath, coughing, chest pain or fatigue. Therefore, a special interdisciplinary consultation was built. The consulatation is not only addressed to people who have been hospitalized due to COVID-19, but also to those with mild symptoms during infection. During the consultation hours, personal health data are collected that serves as the basis for this research project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with long COVID syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Long COVID syndrome\n* age \\>= 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04793269', 'briefTitle': 'Characteristics of Long COVID-19 Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Long COVID Syndrom: Charakterisierung Eines Neuen Krankheitsbildes', 'orgStudyIdInfo': {'id': '2021-00280'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long COVID', 'description': 'Patients with long COVID syndrome', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Long COVID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Christian F Clarenbach, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Zurich, Pulmonology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be shared on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Clarenbach', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'Christian Clarenbach', 'investigatorAffiliation': 'University of Zurich'}}}}