Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT05545332
Status:
RECRUITING
Last Update Posted:
2022-09-19
First Post:
2022-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Multidisciplinary Post-COVID-19 Registry Tyrol
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence rates of post-COVID patients requiring multidisciplinary care.', 'timeFrame': '2 years', 'description': 'To quantify disease burden by prevalence rates of post-COVID patients requiring multidisciplinary care.'}, {'measure': 'Characterisation of symptom patterns associated with impaired functional status.', 'timeFrame': 'up to 24 months', 'description': 'Characterisation of symptom patterns associated with impaired post covid-19 functional status scale ≥ 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['post COVID-19 syndrom', 'long COVID', 'long term sequelae'], 'conditions': ['Post COVID-19 Condition']}, 'descriptionModule': {'briefSummary': 'Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (\\> 12 weeks) after COVID-19 in a multidisciplinary care model.', 'detailedDescription': 'Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories.\n\nWith this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients will be screened by primary physicians in Tyrol (Wester Austria) using the post-COVID-19 functional status (PCFS) scale to assess the functional status, and a symptom checklist for the presence and severity of the 10 most common symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with persistent post COVID symptoms ≥ 12 weeks\n* post COVID functional status scale (PCFS) ≥ 2\n\nExclusion Criteria:\n\n* observation time after infection \\< 12 weeks\n* PCFS \\< 2'}, 'identificationModule': {'nctId': 'NCT05545332', 'acronym': 'PRECISE', 'briefTitle': 'Prospective Multidisciplinary Post-COVID-19 Registry Tyrol', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Prospective Multidisciplinary Post-COVID-19 Registry Tyrol', 'orgStudyIdInfo': {'id': '1450/2021_V2_10_02_2022'}}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Judith Löffler-Ragg, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Judith M Löffler-Ragg', 'role': 'CONTACT', 'email': 'judith.loeffler@i-med.ac.at', 'phone': '+43 512 504', 'phoneExt': '81413'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning three months after publication and ending five years following article publication.', 'ipdSharing': 'YES', 'description': 'We provide all of the individual participant data collected during the trial after deidentification and to researchers who provide a methodologically sound proposal.', 'accessCriteria': 'Access to researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}