COVID-19GERICOVIDNCT05455892
Mortality, Gravity Predictive Factors and Clinical Evolution of Older COVID-19 Patients in Short Geriatric Services.
An observational study of COVID-19, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
Since the beginning of the year 2020, clinical characteristics of a new disease as the global COVID-19 epidemic has spread in France. People over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Clinical data collection during hospitalization in short geriatric units.
- How many people
- 450 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Jul 2020to 30 Sep 2022
- 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: The study was proposed to all patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon between 1er March 2020 and 30th June 2020.
Who may be able to join
- Patient over 70 years of age.
- Patient hospitalized in short geriatric units in University Hospital of Lyon.
- Patient diagnosed with COVID-19 (positive Polymerase Chain Reaction or a high presumption of COVID-19 based on clinical and/or scannographic evidence).
- Patient Informed and non-opposed to the research (Patient informed of the study by his medical doctor during hospitalization or by post, thanks to a generic information sheet dedicated to COVID-19 researches).
Who cannot join
- Patient opposed to the research.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service de gériatrie aigue de l'hôpital de la Croix Rousse. Hospices Civils de Lyon
Caluire-et-Cuire, Rhone, 69300
Service de gériatrie aigue de l'hôpital Edouard Herriot, Pavillon T. Hospices Civils de Lyon
Lyon, Rhone, 69003
Service de gériatrie aigue de l'hôpital Edouard Herriot. Hospices Civils de Lyon
Lyon, Rhone, 69003
Service de gériatrie aigue de l'hôpital Lyon Sud. Hospices Civils de Lyon
Pierre-Bénite, Rhone, 69495
Service de gériatrie aigue de l'hôpital des Charpennes. Hospices Civils de Lyon
Villeurbanne, Rhone, 69100
About this study
Official title: Analysis of Mortality, Gravity Predictive Factors and Evolution of Clinical Characteristics of Older Patients Hospitalized for COVID-19 in Short Geriatric Services.
Since the beginning of the year 2020, clinical characteristics of a new disease as the global COVID-19 epidemic has spread in France. People over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. Evolution of the disease is variable from forms with few symptoms to severe forms sometimes quickly lethal.
GERICOVID LYON is a descriptive analysis of all patients over 70 years of age hospitalised for COVID-19 in short geriatric unities of University Hospital of Lyon This study will allow more comprehension about COVID-19 in older people. The role of predictive factors, pre-existing comorbidities and the nature and frequency of complications in a short period will be investigate. Treatments practices will be analysed too.
- Conditions
- COVID-19
- Being tested
- Clinical data collection during hospitalization in short geriatric units.
- Keywords
- ELDERLY, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collection during hospitalization in short geriatric units.Other
Retrospective clinical data collection, at time of infection and 10 days later. Correlation between mortality and gravity. Identification of predictive mortality factors such as frailty, preexisting comorbidities, complications and treatments. Description of medical prescription evolutions.
| Study group | Role | What they receive |
|---|---|---|
| Elder patients hospitalized for COVID-19 in geriatric short stay units. | All patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon, who agree with retrospective collection of their clinical datas. Receives: Other: Clinical data collection during hospitalization in short geriatric units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality rate.
Observed mortality rate will be presented with its 95% confidence interval.
Measured: During patient hospitalization, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start23 Jul 2020
- Primary completion1 Nov 2021
- Study completion30 Sep 2022 (estimated)
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455892
- Sponsor's protocol ID
- AGORA n°36
- Acronym
- GERICOVID
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mortality, Gravity Predictive Factors and Evolution of Clinical Characteristics of Older Patients Hospitalized for COVID-19 in Short Geriatric Services.
- ClinicalTrials.gov ID
- NCT05455892
- Acronym / sponsor ID
- GERICOVID / AGORA n°36
- Conditions
- COVID-19
- Keywords
- ELDERLY, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Jul 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.
Since the beginning of the year 2020, clinical characteristics of a new disease as the global COVID-19 epidemic has spread in France. People over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. Evolution of the disease is variable from forms with few symptoms to severe forms sometimes quickly lethal.
GERICOVID LYON is a descriptive analysis of all patients over 70 years of age hospitalised for COVID-19 in short geriatric unities of University Hospital of Lyon This study will allow more comprehension about COVID-19 in older people. The role of predictive factors, pre-existing comorbidities and the nature and frequency of complications in a short period will be investigate. Treatments practices will be analysed too.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elder patients hospitalized for COVID-19 in geriatric short stay units. | – | Other: Clinical data collection during hospitalization in short geriatric units.All patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon, who agree with retrospective collection of their clinical datas. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study was proposed to all patients over 70 years of age, with a positive Polymerase Chain Reaction or a high presumption of COVID-19, hospitalized in short geriatric units in University Hospital of Lyon between 1er March 2020 and 30th June 2020.
Key inclusion criteria (4 listed)
- Patient over 70 years of age.
- Patient hospitalized in short geriatric units in University Hospital of Lyon.
- Patient diagnosed with COVID-19 (positive Polymerase Chain Reaction or a high presumption of COVID-19 based on clinical and/or scannographic evidence).
- Patient Informed and non-opposed to the research (Patient informed of the study by his medical doctor during hospitalization or by post, thanks to a generic information sheet dedicated to COVID-19 researches).
Key exclusion criteria (1 listed)
- Patient opposed to the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical data collection during hospitalization in short geriatric units.Retrospective clinical data collection, at time of infection and 10 days later. Correlation between mortality and gravity. Identification of predictive mortality factors such as frailty, preexisting comorbidities, complications and treatments. Description of medical prescription evolutions. | Other | Elder patients hospitalized for COVID-19 in geriatric short stay units. |
Primary outcome
In hospital mortality rate.
Time frame: During patient hospitalization, an average of 10 days.
Observed mortality rate will be presented with its 95% confidence interval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
5 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, run by Hospices Civils de Lyon at 5 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 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
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?
In hospital mortality rate. (time frame: During patient hospitalization, an average of 10 days.). 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 20 Jul 2022.