Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04677283 |
| Other study ID # |
2020-A01027-32 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 7, 2020 |
| Est. completion date |
July 8, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
Gérond'if |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will
be the combination of PCR results and symptomatology, making it possible to define positive
cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained
can be compared with the results of serology if these are performed.
Description:
This study is taking place in several nursing homes in Ile-de-France, which will be recruited
at the end of the diagnostic campaign.
At the initiative of the ARS Ile-de-France, residents and professionals of selected EHPADs
will be subjected to systematic screening by RT-PCR for Covid-19, then by serology after the
first screening, regardless of whether either the result
Samples, by nasopharyngeal swab for RT-PCR, by capillary blood sampling or venipuncture
according to the technique for serology, will be carried out according to the doctrines
issued by the ARS Ile de France and the variations proposed by the appropriate departmental
directorates in depending on local resources. The results will be brought to the attention of
EHPADs to adapt the care of residents and positive professionals.
Data will be collected daily from collection for the first test (RT-PCR), or retrospectively
if the collection took place before the study.
Regarding the approach for collecting serologies:
- All subjects included with a negative PCR will be offered the serological test, in
accordance with the recommendations in force or the medical decisions of the
establishments.
- The qualitative results of the serologies of the subjects included in the study
(residents and professionals) will be collected according to the same circuit as those
of the RT-PCRs.
- Only the symptoms of residents with a positive serology will be collected, from the date
of the sample and for a period of 14 days.
- The symptoms of professionals with a positive serology can be collected, from the date
of the sample and for a period of 14 days without mandatory character.
- Both techniques (ELISA or TROD) are accepted and the serology values will not be
collected.
