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

• Conditions: COVID-19; Elderly Patient

• Registration Number: NCT05184166
• Lead Sponsor: Centre Hospitalier le Mans

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-04
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-07
• Last Update Submitted: 2022-01-07
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-24
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Du Mans; 🇫🇷 Le Mans, France