SARS-CoV 2CovAgedNCT04414319
Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly
An observational study of SARS-CoV 2, run by University Hospital Center of Martinique at 5 sites in 3 countries.
Trial summary
In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- SARS-CoV 2
- How many people
- 170 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Apr 2020to 13 Apr 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
- Older adult
Study population: A cohort of covid-19 patients aged 70 years or older, admitted in a short stay or a rehabilitation geriatric wards.
Who may be able to join
- 70 years of age or older;
- Hospitalized in a short stay or a rehabilitation geriatric wards at one of the participating centers;
- Positive by Reverse Transcriptase-Polymerase Chain Reaction for severe acute respiratory syndrome (SARS-CoV-2) coronavirus or be considered to have SARS-CoV-2 coronavirus based on lung CT data and physician opinion;
- Formal consent to answer the questionnaire or, in the event of inability to give consent, consent obtained from the trusted third party;
- Affiliation to a social security scheme.
Who cannot join
- Patient under formal guardianship or trusteeship.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France3 sites
University hospital of Rennes
Rennes, 35000
Va de Lys-Ramsay Gds group Clinic
Tourcoing, 59200
Hopsital of Valenciennes
Valenciennes, 59300
About this study
Official title: Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy
In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the severe acute respiratory syndrome (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. the investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.
Read the detailed description
The question of the outcome of elderly populations in the immediate aftermath of the epidemic and at a distance from it are essential to measure the effectiveness of the medical care that has been undertaken, but also to adapt the response to the specific problems of the elderly population. It is likely that the older, more fragile population will take longer to recover from the epidemic than the younger population because their functional reserves prior to coronavirus disease 19 are lower. In addition, the possible consequences of containment must be added to the burden of co-morbidities and dependence prior to the epidemic. Containment is synonymous with a restriction in social relationship, and sometimes a reduction in the support provided on a daily basis to frail or even dependent elderly people. Moreover, containment alone may be responsible for the onset or worsening of pathologies.
In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. The investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.
- Conditions
- SARS-CoV 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of autonomy
Loss of autonomy (based on the variation of activity of daily living and instrumental activities of daily living score, and new formal or informal help)
Measured: 36 months
Secondary outcomes (4)
Hospital readmission
Any new hospitalization not scheduled during follow-up. We we will also study early re-hospitalizations (occurring within 30 days or less).
Measured: 1 month follow-up
Nursing home admission
for non-institutionalized persons at inclusion) by a change of residence, from the usual place of residence to a lodging establishment for people dependent elderly, or to a long-term care unit
Measured: 36 months
All-cause mortality
Death considered will be those occurring between inclusion and the end of follow-up
Measured: Inclusion and 36 months
change in self-rated health
Self-rated health will be rated as: very good, good bad, very bad. The transition during monitoring to a less favorable modality than that announced at inclusion will be considered as a perceived deterioration in health
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Apr 2020
- Primary completion15 Apr 2021
- Study completion13 Apr 2023
Why it stopped: Lack of time to realize the research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies 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
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moustapha DRAME, PHD, Study director, Unversity hospital of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414319
- Sponsor's protocol ID
- 20_RIPH3-02
- Acronym
- CovAged
- Status last verified
- Jul 2023
- First submitted
- 18 May 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy
- ClinicalTrials.gov ID
- NCT04414319
- Acronym / sponsor ID
- CovAged / 20_RIPH3-02
- Conditions
- SARS-CoV 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of time to realize the research
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 4 Jun 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.
In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the severe acute respiratory syndrome (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. the investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.
Detailed description
The question of the outcome of elderly populations in the immediate aftermath of the epidemic and at a distance from it are essential to measure the effectiveness of the medical care that has been undertaken, but also to adapt the response to the specific problems of the elderly population. It is likely that the older, more fragile population will take longer to recover from the epidemic than the younger population because their functional reserves prior to coronavirus disease 19 are lower. In addition, the possible consequences of containment must be added to the burden of co-morbidities and dependence prior to the epidemic. Containment is synonymous with a restriction in social relationship, and sometimes a reduction in the support provided on a daily basis to frail or even dependent elderly people. Moreover, containment alone may be responsible for the onset or worsening of pathologies.
In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. The investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- A cohort of covid-19 patients aged 70 years or older, admitted in a short stay or a rehabilitation geriatric wards.
Key inclusion criteria (5 listed)
- 70 years of age or older;
- Hospitalized in a short stay or a rehabilitation geriatric wards at one of the participating centers;
- Positive by Reverse Transcriptase-Polymerase Chain Reaction for severe acute respiratory syndrome (SARS-CoV-2) coronavirus or be considered to have SARS-CoV-2 coronavirus based on lung CT data and physician opinion;
- Formal consent to answer the questionnaire or, in the event of inability to give consent, consent obtained from the trusted third party;
- Affiliation to a social security scheme.
Key exclusion criteria (1 listed)
- Patient under formal guardianship or trusteeship.
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
Loss of autonomy
Time frame: 36 months
Loss of autonomy (based on the variation of activity of daily living and instrumental activities of daily living score, and new formal or informal help)
4 secondary outcomes
Hospital readmission
Time frame: 1 month follow-up
Nursing home admission
Time frame: 36 months
All-cause mortality
Time frame: Inclusion and 36 months
change in self-rated health
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Lack of time to realize the research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Moustapha DRAME, PHD study director
Unversity hospital of Martinique
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2, run by University Hospital Center of Martinique at 5 sites in 3 countries.
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 5 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: stopped early, as of the sponsor's last update on 20 Jul 2023. 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, Guadeloupe, Martinique. 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 was stopped early (reason given: Lack of time to realize the research). 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?
Loss of autonomy (time frame: 36 months). 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 2023.