Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT05184166
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2022-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe 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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection', 'timeFrame': '6 months', 'description': 'The mortality was evaluated by the proportion of patients aged 70 years and over who died 1 year after diagnosis of SARS-CoV-2 infection who had severe acute respiratory failure defined by at least 4 L/min of oxygen therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'ELDERLY PATIENT'], 'conditions': ['COVID-19', 'Elderly Patient']}, 'descriptionModule': {'briefSummary': "SARS-COV-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the ICU in 5-20% of affected patients. Age is a major risk factor for developing a severe form and for death. ARDS related to SARS-COV-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. These specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). To investigator's knowledge, no study has evaluated the prognosis in the ICU and the long-term functional outcome of elderly people admitted for a severe or critical form of COVID-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...).\n\nInvestigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of COVID-19. The objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe COVID-19."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 70 years and over with severe COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 70 years on admission to hospital\n* diagnosis of SARS-CoV-2 infection defined by a positive RT-PCR test\n* medical or critical care hospitalisation between 1 July 2020 and 31 August 2021\n* who experienced severe hypoxaemic acute respiratory failure defined as at least 4L/min of oxygen during hospitalisation\n\nExclusion Criteria:\n\n* Oxygen therapy \\< 4L/min during hospitalisation\n* Mc Cabe score 3 (chronic disease fatal at 1 year such as stage IV heart failure, ventilated respiratory failure, metastatic cancer, Child C cirrhosis)\n* dementia or cognitive disorders before hospitalisation reported in the medical record\n* patient GIR 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle\n* patient with an ADL score \\< 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle\n* patient living in EHPAD before hospitalisation\n* non-French speaking patient\n* patient under guardianship or curatorship\n* refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person'}, 'identificationModule': {'nctId': 'NCT05184166', 'acronym': 'ELDERCOV', 'briefTitle': 'Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19', 'orgStudyIdInfo': {'id': 'CHM-2021/S03/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '+33244710781'}, {'name': 'Nicolas CHUDEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '+33244710781'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}