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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Elderly Patient

• Study Type: Observational
• Enrollment (Actual): 361

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • CHU Angers
  • Le Mans, France, 72000
    • Centre Hospitalier du Mans
  • Rennes, France, 35000
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 70 years and over with severe COVID-19

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year after diagnosis of SarS-CoV-2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall hospital mortality among included patients	Mortality was evaluated by proportion of patients included who died during their stay at the participating center	during hospitalization
In-hospital mortality among patients admitted to and not admitted to intensive care	Mortality was ecaluated by proportion of patients not admitted to intensive care who died during their stay in the participating center and proportion of patients admitted to intensive care who died in intensive care and during their stay in the participating center	end of hospitalization
Mortality 1 year after diagnosis of SARS-CoV-2 infection in patients who were discharged alive from hospital in the overall cohort and according to whether or not they were admitted to intensive care.	Mortality was evaluated by Proportion of patients who died 1 year after diagnosis of SARS-CoV-2 infection among subjects included and discharged alive from the participating center, in the overall cohort and then according to whether or not they were admitted to intensive care.	1 year after diagnosis of SarS-CoV-2
Outcome for patients admitted and discharged alive from hospital in terms of Quality of life	Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)	1 year after diagnosis of SarS-CoV-2
Outcome for patients admitted and discharged alive from hospital in terms of functionnal status	Functionnal status was evaluated by Activities of Daily Living Scale (from 0 to 6), by Clinical Fragility Score - CFS (7 levels of frailty (from excellent health to severe frailty)) and proportion of patients institutionalized in residential care facilities for dependent elderly people (EHPAD) or in long-term care units (USLD)	1 year after diagnosis of SarS-CoV-2
Hospital care for patients not admitted to intensive care	Proportion of patients admitted to intensive care and not admitted to intensive care	during hospitalization
Risk factors associated with 1-year outcomes in patients surviving hospitalization in the overall cohort and in the cohort of patients admitted to intensive care.	The outcome for patients will be defined as good prognosis (patient alive with an ADL score ≥ 4) and poor prognosis (patient alive with an ADL score < 4 or deceased patient).	1 year after diagnosis SARS-CoV-2

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: COVID-19; ELDERLY PATIENT
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: CHM-2021/S03/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No