Covid19GERIA-COVIDNCT04560608
Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19
An observational study of Covid19, run by University Hospital, Angers at 1 site in France.
Trial summary
Statement : The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Covid19
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2020to 31 Dec 2022
- How long will I take part?
- 12 Months
- 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: All consecutive patients meeting the eligibility criteria over the study period.
Who may be able to join
- Hospitalization in the Geriatric unit of the University Hospital (UH) of Angers from 15/03/2020 and until the closure of the COVID-19 geriatric sector
Who cannot join
- Opposition to the use of the information collected for research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers, 49933
Cedric ANNWEILER, MD, PhD, (+33)241354725, cedric.annweiler@chu-angers.fr
About this study
Statement :
- The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.
- The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.
- To date, there is no effective model for predicting the severity of COVID-19 in an individual.
The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.
- Conditions
- Covid19
- Keywords
- elderly, coronavirus disease
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical history and co-morbidities
listing of medical history and co-morbidities data provided by the physician and the family during hospitalization
Measured: baseline
The physical examination data, and reports of relevant investigations data provided by the physician and the family during hospitalization
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Measured: baseline
Electrocardiography QT Interval
all electrocardiograms performed during hospitalization
Measured: baseline
Number of different therapeutic classes
Number of different therapeutic classes taken per day.
Measured: baseline
Comprehensive Geriatric Assessment (CGA)
Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging. CGA is based on the premise that a systematic evaluation of frail older persons by a team of health professionals may identify a variety of treatable health problems and lead to better health outcomes.
Measured: baseline
Biological parameters
Characterization of the COVID-19 impact on the biological parameters evaluated by blood test.
Measured: baseline
Medical imaging results
Assessment of lesion extension (percent) with medical imaging results (thoracic scan)
Measured: baseline
Diagnosis of COVID-19
Recovery of the diagnosis method (PCR or thoracic scan)
Measured: baseline
Length of hospitalization
Measured: at the 3-month follow-up
Number of death from any cause
Measured: at the 3-month follow-up
Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Measured: at the 3-month follow-up
Length of hospitalization
Measured: at the 12-month follow-up
Number of death from any cause
Measured: at the 12-month follow-up
Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Measured: at the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Mar 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Enrolment
- 700 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric ANNWEILER, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560608
- Sponsor's protocol ID
- 2020/100
- Other IDs
- ar20-0087v0
- Acronym
- GERIA-COVID
- Status last verified
- Dec 2021
- First submitted
- 8 Sep 2020
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Briere O, Otekpo M, Asfar M, Gautier J, Sacco G, Annweiler C; GERIA-COVID study group. Initial functional disability as a 1-year prognostic factor in geriatric patients hospitalized with SARS-CoV-2 infection. PLoS One. 2023 Jul 27;18(7):e0289297. doi: 10.1371/journal.pone.0289297. eCollection 2023.
PubMed 37498909
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19
- ClinicalTrials.gov ID
- NCT04560608
- Acronym / sponsor ID
- GERIA-COVID / 2020/100
- Conditions
- Covid19
- Keywords
- elderly, coronavirus disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Sep 2020 (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.
Statement :
- The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.
- The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.
- To date, there is no effective model for predicting the severity of COVID-19 in an individual.
The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All consecutive patients meeting the eligibility criteria over the study period.
Key inclusion criteria (1 listed)
- Hospitalization in the Geriatric unit of the University Hospital (UH) of Angers from 15/03/2020 and until the closure of the COVID-19 geriatric sector
Key exclusion criteria (1 listed)
- Opposition to the use of the information collected for research purposes.
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
Medical history and co-morbidities
Time frame: baseline
listing of medical history and co-morbidities data provided by the physician and the family during hospitalization
The physical examination data, and reports of relevant investigations data provided by the physician and the family during hospitalization
Time frame: baseline
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Electrocardiography QT Interval
Time frame: baseline
all electrocardiograms performed during hospitalization
Number of different therapeutic classes
Time frame: baseline
Number of different therapeutic classes taken per day.
Comprehensive Geriatric Assessment (CGA)
Time frame: baseline
Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging. CGA is based on the premise that a systematic evaluation of frail older persons by a team of health professionals may identify a variety of treatable health problems and lead to better health outcomes.
Biological parameters
Time frame: baseline
Characterization of the COVID-19 impact on the biological parameters evaluated by blood test.
Medical imaging results
Time frame: baseline
Assessment of lesion extension (percent) with medical imaging results (thoracic scan)
Diagnosis of COVID-19
Time frame: baseline
Recovery of the diagnosis method (PCR or thoracic scan)
Length of hospitalization
Time frame: at the 3-month follow-up
Number of death from any cause
Time frame: at the 3-month follow-up
Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up
Time frame: at the 3-month follow-up
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Length of hospitalization
Time frame: at the 12-month follow-up
Number of death from any cause
Time frame: at the 12-month follow-up
Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up
Time frame: at the 12-month follow-up
The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Derived from this study: PubMed 37498909Briere O, Otekpo M, Asfar M, Gautier J, Sacco G, Annweiler C; GERIA-COVID study group. Initial functional disability as a 1-year prognostic factor in geriatric patients hospitalized with SARS-CoV-2 infection. PLoS One. 2023 Jul 27;18(7):e0289297. doi: 10.1371/journal.pone.0289297. eCollection 2023.
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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.
Cédric ANNWEILER, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Angers at 1 site 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 1 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Cédric ANNWEILER, MD, PhD (02 41 35 47 25 ext. +33, cedric.annweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical history and co-morbidities (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560608, which also lists 1 linked publication.
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 Dec 2021.