Clinical trial NCT05184166: Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19
Official title: Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Elderly Patient
Keywords: COVID-19
ELDERLY PATIENT
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 450
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 70 years and over with severe COVID-19

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.


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

Primary outcomes:
measure: Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References: