Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT06468761
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-year Mortality After COVID-19 in Nursing Home Residents
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Older Adults', 'Nursing home', 'Long-tem mortality'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '315 residents of 3 nursibg omes, mean age 86 years old. 50% severe disability. 111 contracted COVID-19 and survived the first pandemic wave.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in one of the Nursing Homes during the fiorst COVID-19 pandemic wave\n* Having survived the first pandemic wave\n\nExclusion Criteria:\n\n* Residents who died during the first pandemic wave\n* Refusal for articipation to the study'}, 'identificationModule': {'nctId': 'NCT06468761', 'briefTitle': '2-year Mortality After COVID-19 in Nursing Home Residents', 'organization': {'class': 'OTHER', 'fullName': 'Bichat Hospital'}, 'officialTitle': 'COVID-19 Infection and 2-year Mortality in Nursing Home Residents Who Survived the First Wave of the Pandemic', 'orgStudyIdInfo': {'id': '22021'}}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Department of Geriatrics', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bichat Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md PhD', 'investigatorFullName': 'Manuel Sanchez', 'investigatorAffiliation': 'Bichat Hospital'}}}}