Clinical trial NCT04677283: Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.
Official title: Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptoms Related to Covid-19
Keywords: Covid-19
serology
Reverse Transcriptase PCR
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 1059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two types of population, EHPAD residents identified and EHPAD professionals

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. / Residents of nursing homes in Île-de-France in which systematic Covid-19 screening tests were carried out and agreeing to participate in the study.
2. / Professionals in nursing homes in Île-de-France in which systematic screening tests for Covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc.

Exclusion Criteria:

1. / Expression of opposition to the collection of symptoms by professionals, residents or their legal representatives.
2. / Subjects who have not had a diagnostic test by RT-PCR.

Primary outcomes:
measure: To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies
timeFrame: 3 Months
Secondary outcomes:
measure: Assessment of commorbidity risk according Charlson score
timeFrame: 3 Months
measure: Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
timeFrame: 3 Months
measure: Assessment of teh degree of autonomy according AGGIR score
timeFrame: 3 Months
measure: Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores
timeFrame: 3 Months
measure: Screening for a nutritional disorder according Body Mass Index (BMI) score
timeFrame: 3 Months
Other outcomes:
Locations:
city: Paris
country: France
facility: Autonomy Department; ARS Île-de-France
state: ARS Île-de-France
Study officials:
affiliation: Autonomy Department; ARS Île-de-France
name: Martine LE NOC - SOUDANI, MD
role: STUDY_CHAIR
References: