Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-27 @ 1:36 PM
Study NCT ID:
NCT05359159
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2022-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Greater understanding of SARS-CoV-2 disease', 'timeFrame': '24 months', 'description': 'Greater understanding of SARS-CoV-2 disease and its long-term manifestations. To this end, the clinical manifestations, any alterations in laboratory and instrumental parameters will be evaluated to identify organ damages and calculate its prevalence'}], 'secondaryOutcomes': [{'measure': 'Measurement of psychological impact of SARS-CoV-2 disease', 'timeFrame': '24 months', 'description': 'Understanding the impact of the disease and its sequelae on daily life and the impact on the psychological aspect of the person;'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long-COVID', 'post-COVID', 'SarS-CoV2'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'People affected by SARS-CoV-2 infection, whether patients have developed mild forms or a severe form of the disease, complain of nonspecific and entirely new symptoms or complain about the persistence pf them.Investigators intend to follow over time the post-infectious phase of patients discharged from sub-intensive care unit. The aim is to identify symptoms and their frequency of presentation in the SARS-CoV-2 population in the post-acute period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients admitted to Ospedale San Salvatore dell'Aquila over 18 years during Sars-CoV2 pandemics, with or without Sars-CoV2 related disease", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18\n\nExclusion Criteria:\n\n* Patients under 18'}, 'identificationModule': {'nctId': 'NCT05359159', 'briefTitle': 'Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment', 'organization': {'class': 'OTHER', 'fullName': "University of L'Aquila"}, 'officialTitle': 'Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment', 'orgStudyIdInfo': {'id': '66848'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-COVID patients', 'description': 'Patients recovered from Sars-CoV2 infection', 'interventionNames': ['Other: Data collection']}, {'label': 'healthy control patients', 'description': 'Patients who did not have Sars-CoV2', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collection', 'armGroupLabels': ['Post-COVID patients', 'healthy control patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'state': "Italy/L'Aquila", 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara Balsano', 'role': 'CONTACT', 'email': 'clara.balsano@univaq.it', 'phone': '+390862434774'}], 'facility': 'Clara Balsano', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '67100', 'city': 'L’Aquila', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara Balsano', 'role': 'CONTACT', 'email': 'clara.balsano@univaq.it', 'phone': '+39 0862434774'}], 'facility': "University of L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}], 'centralContacts': [{'name': 'Clara Balsano', 'role': 'CONTACT', 'email': 'clara.balsano@univaq.it', 'phone': '00390862434774'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Clara Balsano', 'investigatorAffiliation': "University of L'Aquila"}}}}