COVID-19ELDERCOVNCT05184166
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19
An observational study of COVID-19 and Elderly Patient, run by Centre Hospitalier le Mans at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- COVID-19, Elderly Patient
- How many people
- 361 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Mar 2022to 11 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 70 years and over with severe COVID-19
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu Angers
Angers, 49000
Centre Hospitalier Du Mans
Le Mans, 72000
Chu Rennes
Rennes, 35000
About this study
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
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after diagnosis of SarS-CoV-2
Secondary outcomes (7)
Overall hospital mortality among included patients
Mortality was evaluated by proportion of patients included who died during their stay at the participating center
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 1 year after diagnosis SARS-CoV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start24 Mar 2022
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184166
- Sponsor's protocol ID
- CHM-2021/S03/10
- Acronym
- ELDERCOV
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19
- ClinicalTrials.gov ID
- NCT05184166
- Acronym / sponsor ID
- ELDERCOV / CHM-2021/S03/10
- Conditions
- COVID-19, Elderly Patient
- Keywords
- COVID-19, ELDERLY PATIENT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 70 years and over with severe COVID-19
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Time frame: 1 year after diagnosis of SarS-CoV-2
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
7 secondary outcomes
Overall hospital mortality among included patients
Time frame: during hospitalization
In-hospital mortality among patients admitted to and not admitted to intensive care
Time frame: 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.
Time frame: 1 year after diagnosis of SarS-CoV-2
Outcome for patients admitted and discharged alive from hospital in terms of Quality of life
Time frame: 1 year after diagnosis of SarS-CoV-2
Outcome for patients admitted and discharged alive from hospital in terms of functionnal status
Time frame: 1 year after diagnosis of SarS-CoV-2
Hospital care for patients not admitted to intensive care
Time frame: 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.
Time frame: 1 year after diagnosis SARS-CoV-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Elderly Patient, run by Centre Hospitalier le Mans at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection (time frame: 1 year after diagnosis of SarS-CoV-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.