Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT05261061
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2022-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19
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': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One-year mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Activity of daily living (ADL) at 1 year', 'timeFrame': '1 year'}, {'measure': 'SF-12 at one year', 'timeFrame': '1 year', 'description': 'Quality of life'}, {'measure': 'Clinical Frailty Scale (CFS) at one year', 'timeFrame': '1 year'}, {'measure': 'rehospitalization at one year', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', '1-year prognosis', 'older patients'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Old patients hospitalized in Acute Geriatric Units are characterize by advanced age, frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy. Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors).\n\nFor geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.', 'detailedDescription': 'Old patients hospitalized in Acute Geriatric Units are characterize by advanced age (average 85 years), frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy.These particular state leads to multiple decompensations and the reason for initial hospitalization is often only the "tip of the iceberg". Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors).\n\nFor geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). This excess mortality is all the more surprising as these patients seem to have fewer comorbidities than those usually hospitalized in acute geriatric units.\n\nOur hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients hospitalized in acute geriatric unit for medical reason (COVID or other)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=75 years\n* Hospitalized for medical reason in acute geriatric unit\n* Alive at hospital discharge\n\nExclusion Criteria:\n\n* Patients hospitalized for surgical reason\n* Patients under legal protection\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT05261061', 'acronym': 'PROVID-Ger', 'briefTitle': 'Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19', 'orgStudyIdInfo': {'id': 'APHP211505'}, 'secondaryIdInfos': [{'id': 'IDRCB 2021-A02684-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Old patients hospitalized in acute geriatric unit'}, {'label': 'Old patients hospitalized for other medical diagnosis in acute geriatric unit'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Hélène VALLET, MD, PhD', 'role': 'CONTACT', 'email': 'Helene.vallet@aphp.fr', 'phone': '+33149282042'}], 'facility': 'Service de gériatrie, Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Hélène VALLET, MD, PhD', 'role': 'CONTACT', 'email': 'Helene.vallet@aphp.fr', 'phone': '+33149282042'}], 'overallOfficials': [{'name': 'Hélène VALLET, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP- Sorbonne université'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}