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Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19 (ELDERCOV)

30 de junio de 2026 actualizado por: Centre Hospitalier le Mans

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

Terminado

Tipo de estudio

De observación

Inscripción (Actual)

361

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Angers, Francia, 49000
        • CHU Angers
      • Le Mans, Francia, 72000
        • Centre Hospitalier du Mans
      • Rennes, Francia, 35000
        • Chu Rennes

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

70 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Patients aged 70 years and over with severe COVID-19

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
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
1 year after diagnosis of SarS-CoV-2

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall hospital mortality among included patients
Periodo de tiempo: during hospitalization
Mortality was evaluated by proportion of patients included who died during their stay at the participating center
during hospitalization
In-hospital mortality among patients admitted to and not admitted to intensive care
Periodo de tiempo: end of hospitalization
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
end of hospitalization
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
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.
1 year after diagnosis of SarS-CoV-2
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
Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)
1 year after diagnosis of SarS-CoV-2
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
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)
1 year after diagnosis of SarS-CoV-2
Hospital care for patients not admitted to intensive care
Periodo de tiempo: during hospitalization
Proportion of patients admitted to intensive care and not admitted to intensive care
during hospitalization
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
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).
1 year after diagnosis SARS-CoV-2

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de marzo de 2022

Finalización primaria (Actual)

11 de diciembre de 2023

Finalización del estudio (Actual)

11 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

7 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

7 de enero de 2022

Publicado por primera vez (Actual)

11 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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