- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414319
Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly (CovAged)
Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Rennes, France, 35000
- University Hospital of Rennes
-
Tourcoing, France, 59200
- Va de Lys-Ramsay Gds group Clinic
-
Valenciennes, France, 59300
- Hopsital of Valenciennes
-
-
-
-
-
Les Abymes, Guadeloupe, 97139
- University Hospital of Guadeloupe
-
-
-
-
-
Fort-de-France, Martinique, 97261
- University Hospital of Martinique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient under formal guardianship or trusteeship.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital readmission
Time Frame: 1 month follow-up
|
Any new hospitalization not scheduled during follow-up.
We we will also study early re-hospitalizations (occurring within 30 days or less).
|
1 month follow-up
|
Nursing home admission
Time Frame: 36 months
|
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
|
36 months
|
All-cause mortality
Time Frame: Inclusion and 36 months
|
Death considered will be those occurring between inclusion and the end of follow-up
|
Inclusion and 36 months
|
change in self-rated health
Time Frame: 36 months
|
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
|
36 months
|
Collaborators and Investigators
Investigators
- Study Director: Moustapha DRAME, PHD, Unversity hospital of Martinique
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20_RIPH3-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SARS-CoV 2
-
Argorna Pharmaceuticals Co., LTDCompleted
-
Argorna Pharmaceuticals Co., LTDCompleted
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Active, not recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Active, not recruiting
-
Arcturus Therapeutics, Inc.Terminated
-
University Hospital Inselspital, BerneUniversity of Bern; Lucerne University of Applied Sciences and ArtsCompleted
-
Centre Hospitalier Universitaire DijonUnknown
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and PreventionNot yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Not yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical CollegeActive, not recruiting