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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05184166
Acronym
ELDERCOV
Enrollment
361
Registered
2022-01-11
Start date
2022-03-24
Completion date
2023-12-11
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Elderly Patient

Keywords

COVID-19, ELDERLY PATIENT

Brief summary

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.

Interventions

None listed

Sponsors

Centre Hospitalier le Mans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection1 year after diagnosis of SarS-CoV-2The 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

MeasureTime frameDescription
Overall hospital mortality among included patientsduring hospitalizationMortality was evaluated by proportion of patients included who died during their stay at the participating center
In-hospital mortality among patients admitted to and not admitted to intensive careend of hospitalizationMortality 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
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.1 year after diagnosis of SarS-CoV-2Mortality 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.
Outcome for patients admitted and discharged alive from hospital in terms of Quality of life1 year after diagnosis of SarS-CoV-2Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)
Outcome for patients admitted and discharged alive from hospital in terms of functionnal status1 year after diagnosis of SarS-CoV-2Functionnal 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)
Hospital care for patients not admitted to intensive careduring hospitalizationProportion of patients admitted to intensive care and not admitted to intensive care
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.1 year after diagnosis SARS-CoV-2The 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026