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NCT Number: NCT05184166

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Elderly Patient Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection

    Time frame: 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

Secondary outcomes

  1. Overall hospital mortality among included patients

    Time frame: during hospitalization

    Mortality was evaluated by proportion of patients included who died during their stay at the participating center

  2. In-hospital mortality among patients admitted to and not admitted to intensive care

    Time frame: 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

  3. 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.

    Time frame: 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.

  4. Outcome for patients admitted and discharged alive from hospital in terms of Quality of life

    Time frame: 1 year after diagnosis of SarS-CoV-2

    Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)

  5. Outcome for patients admitted and discharged alive from hospital in terms of functionnal status

    Time frame: 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)

  6. Hospital care for patients not admitted to intensive care

    Time frame: during hospitalization

    Proportion of patients admitted to intensive care and not admitted to intensive care

  7. 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.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: ELDERCOV

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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