Clinical trial NCT05085522: Study of the Effect of Systematic Screening of Residents and Caregivers With Covid-19 by Nasopharyngeal Swab (RT-PCR)
Official title: Study of the Effect of Systematic Screening of Residents and Caregivers by Nasopharyngeal Swab (RT-PCR) on the Incidence Rate of COVID-19 Infection in Medico-social Institutions for the Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
RT-PCR
SARS-CoV-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.

Brief summary: The current COVID-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures.

Residents of medico-social institutions for the elderly are particularly at risk of developing severe forms because they have a large number of factors favoring the progression to a severe form (very advanced age, multiple comorbidities, dependence in activities of dayli life).

The specificity and positive predictive value of clinical signs are not very important in this population; which makes the diagnosis even more complicated.

One of the strategies to try to protect these residents, in addition to room containment and clinical surveillance, would be to carry out a systematic screening campaign of all residents and all caregivers, then to consider reorganizing the establishments with a sector "COVID +".

This was announced by the French Minister of Health Olivier VERAN on 04/06/2020 from the first confirmed case of COVID-19 in an institution.

However, asymptomatic subjects may have a "negative" RT-PCR test at one point but which is positive in the following days. And in this interval they would still be contagious.

It is therefore not excluded that the implementation of such a screening campaign will not be effective in reducing the number of new cases of COVID-19 in medico-social institutions for the elderly


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject hospitalized in a medico-social institution for the elderly (SMTI or EHPAD) at the HUS or in another center which will be recruited secondarily and whose patients in a unit all have the same attending physician.
* Subject (or family) who did not express their disagreement with the reuse of this data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective study of the effect of systematic screening of residents and caregivers by nasopharyngeal swab (RT-PCR) on the incidence rate of COVID-19 infection
timeFrame: Files analysed retrospectively from March 15, 2020 to July 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
name: Alexandre BOUSSUGE, MD
role: PRINCIPAL_INVESTIGATOR
References: