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

NCT05184166 | Unknown

• 1 other identifier: CHM-2021/S03/10
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; ELDERLY PATIENT

Outcome Measures

Primary Outcomes (1)

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

  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

  6 months

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 70 years and over with severe COVID-19

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 11, 2022
• Study Start: January 4, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

FR (1)