Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT05413694
Status:
UNKNOWN
Last Update Posted:
2022-06-10
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative incidence of patients with "persistent COVID-19"', 'timeFrame': '24 month', 'description': 'presence (at the time of the interview or in the month preceding the interview) of at least one symptom among the most frequent prolonged symptoms of COVID-19 and which was not present before the interview SARS (severe acute respiratory syndrome )-CoV-2 infection'}], 'secondaryOutcomes': [{'measure': 'Determine the factors associated with the persistence of symptoms', 'timeFrame': '24 month'}, {'measure': 'Measure physical and mental quality of life', 'timeFrame': '24 month', 'description': 'Medical Outcome Study Short Form 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The island of Reunion, a French overseas department of 860,000 inhabitants, located in the Indian Ocean (OI) zone, recorded its first case of COVID-19 on March 11, 2020. The epidemic, which was described as not very severe during the year 2020 in Reunion was much more intense and more deadly in 2021, with the arrival of the new variants (South African and Indian) and exploded at the beginning of the year 2022 (variant Omicron).\n\nReunion has a specific island context both climato-geographically and demographically. Indeed, this French island located in the southern hemisphere in the middle of the Indian Ocean (OI) has a tropical climate and a multi-ethnic population, younger than in mainland France (16% are over 60 years old). It is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (\\>10%), recognized as factors favoring severe clinical forms of COVID-19. as well as "persistent COVID-19".\n\nThis study will allow the constitution of a large-scale French cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old\n* having been hospitalized at the University Hospital Center (CHU) of Reunion (minimum of one night in the hospital)\n* with a positive diagnosis of COVID-19 (positive RT(reverse transcription)-PCR(Polymerase Chain Reaction) SARS-CoV-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file)\n* registered in the COVIDEPI database\n* whose telephone numbers are available in the computerized patient file\n* residing on the island of Reunion\n* knowing how to understand and speak French\n\nExclusion Criteria:\n\n* deceased\n* opposing the use of their data\n* deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators'}, 'identificationModule': {'nctId': 'NCT05413694', 'acronym': "COVIDEPI-SUIV'", 'briefTitle': 'Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island', 'orgStudyIdInfo': {'id': '2022/CHU/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'telephone interview 24 months after hospitalization for Covid-19', 'description': 'telephone interview 24 months after hospitalization for Covid-19', 'interventionNames': ['Other: telephone interview 24 months after hospitalization for Covid-19']}], 'interventions': [{'name': 'telephone interview 24 months after hospitalization for Covid-19', 'type': 'OTHER', 'description': 'telephone interview 24 months after hospitalization for Covid-19', 'armGroupLabels': ['telephone interview 24 months after hospitalization for Covid-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97448', 'city': 'Saint-Pierre', 'country': 'Reunion', 'contacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT'}, {'name': 'Léa BRUNEAU, ¨PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'centralContacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT', 'email': 'lucie.auzanneau@chu-reunion.fr', 'phone': '0262359949', 'phoneExt': '+262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}