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Clinical Trials/NCT05184166
NCT05184166
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Not Applicable

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

Centre Hospitalier le Mans1 site in 1 country450 target enrollmentJanuary 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Centre Hospitalier le Mans
Enrollment
450
Locations
1
Primary Endpoint
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2022
End Date
September 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

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

Study Sites (1)

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