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

COVID-19 Clinical Trial

— ELDERCOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05184166
• Other study ID #: CHM-2021/S03/10
• Status: Recruiting
• Start date: January 4, 2022
• Est. completion date: September 2023

Study information

• Verified date: January 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Elderly Patient

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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