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

30 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

361

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

70 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients aged 70 years and over with severe COVID-19

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall hospital mortality among included patients
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de março de 2022

Conclusão Primária (Real)

11 de dezembro de 2023

Conclusão do estudo (Real)

11 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

7 de janeiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de janeiro de 2022

Primeira postagem (Real)

11 de janeiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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