- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05184166
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19 (ELDERCOV)
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...).
Investigator 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Angers, Francia, 49000
- CHU Angers
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Le Mans, Francia, 72000
- Centre Hospitalier du Mans
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Rennes, Francia, 35000
- Chu Rennes
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- age ≥ 70 years on admission to hospital
- diagnosis of SARS-CoV-2 infection defined by a positive RT-PCR test
- medical or critical care hospitalisation between 1 July 2020 and 31 August 2021
- who experienced severe hypoxaemic acute respiratory failure defined as at least 4L/min of oxygen during hospitalisation
Exclusion Criteria:
- Oxygen therapy < 4L/min during hospitalisation
- Mc Cabe score 3 (chronic disease fatal at 1 year such as stage IV heart failure, ventilated respiratory failure, metastatic cancer, Child C cirrhosis)
- dementia or cognitive disorders before hospitalisation reported in the medical record
- patient GIR 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle
- patient with an ADL score < 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle
- patient living in EHPAD before hospitalisation
- non-French speaking patient
- patient under guardianship or curatorship
- refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Periodo de tiempo: 1 year after diagnosis of SarS-CoV-2
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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
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1 year after diagnosis of SarS-CoV-2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall hospital mortality among included patients
Periodo de tiempo: during hospitalization
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Mortality was evaluated by proportion of patients included who died during their stay at the participating center
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during hospitalization
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In-hospital mortality among patients admitted to and not admitted to intensive care
Periodo de tiempo: end of hospitalization
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Mortality was ecaluated by proportion of patients not admitted to intensive care who died during their stay in the participating center and proportion of patients admitted to intensive care who died in intensive care and during their stay in the participating center
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end of hospitalization
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Mortality 1 year after diagnosis of SARS-CoV-2 infection in patients who were discharged alive from hospital in the overall cohort and according to whether or not they were admitted to intensive care.
Periodo de tiempo: 1 year after diagnosis of SarS-CoV-2
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Mortality was evaluated by Proportion of patients who died 1 year after diagnosis of SARS-CoV-2 infection among subjects included and discharged alive from the participating center, in the overall cohort and then according to whether or not they were admitted to intensive care.
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1 year after diagnosis of SarS-CoV-2
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Outcome for patients admitted and discharged alive from hospital in terms of Quality of life
Periodo de tiempo: 1 year after diagnosis of SarS-CoV-2
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Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)
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1 year after diagnosis of SarS-CoV-2
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Outcome for patients admitted and discharged alive from hospital in terms of functionnal status
Periodo de tiempo: 1 year after diagnosis of SarS-CoV-2
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Functionnal status was evaluated by Activities of Daily Living Scale (from 0 to 6), by Clinical Fragility Score - CFS (7 levels of frailty (from excellent health to severe frailty)) and proportion of patients institutionalized in residential care facilities for dependent elderly people (EHPAD) or in long-term care units (USLD)
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1 year after diagnosis of SarS-CoV-2
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Hospital care for patients not admitted to intensive care
Periodo de tiempo: during hospitalization
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Proportion of patients admitted to intensive care and not admitted to intensive care
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during hospitalization
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Risk factors associated with 1-year outcomes in patients surviving hospitalization in the overall cohort and in the cohort of patients admitted to intensive care.
Periodo de tiempo: 1 year after diagnosis SARS-CoV-2
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The outcome for patients will be defined as good prognosis (patient alive with an ADL score ≥ 4) and poor prognosis (patient alive with an ADL score < 4 or deceased patient).
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1 year after diagnosis SARS-CoV-2
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHM-2021/S03/10
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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