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

NCT ID: NCT05184166

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2023-09-30

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.

Conditions

COVID-19; Elderly Patient

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Du Mans

Le Mans, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christelle JADEAU

Role: CONTACT

cjadeau@ch-lemans.fr

+33244710781

Facility Contacts

Christelle JADEAU

Role: primary

cjadeau@ch-lemans.fr

+33244710781

Other Identifiers

CHM-2021/S03/10

Identifier Type: -

Identifier Source: org_study_id