CClinicalTrials.gg
Status unknownNCT05085522INMESO-CovidUpdated Dec 1, 2021

Study of the Effect of Systematic Screening of Residents and Caregivers With Covid-19 by Nasopharyngeal Swab (RT-PCR)

An observational study in COVID-19, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-01.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • RT-PCR
  • SARS-CoV-2
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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 200 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion criteria:

  • Subject having expressed opposition to participating in the study
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Files analysed retrospectively from March 15, 2020 to July 31, 2020 will be examined]

07

Study locations

1 of 1 sites recruiting
  • Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
    • Alexandre BOUSSUGE, MD · Contact · alexandre.boussuge@chru-strasbourg.fr · 33 3 88 11 54 61
    • Saïd CHAYER, PhD, HDR · Contact · said.chayer@chru-strasbourg.fr
    • Alexandre BOUSSUGE, MD · Principal investigator
    • Patrick KARCHER, MD · Sub investigator
    • Denata MUTELICA, MD · Sub investigator
    • Leslie CAVEE, MD · Sub investigator
    • Nicolas TUZIN, Biostatistics engineer · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05085522
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Oct 20, 2021
Start date
Aug 1, 2020
Primary completion
Jan 30, 2022 (estimated)
Completion
Jan 30, 2022 (estimated)
Last update
Dec 1, 2021

Study contacts

Alexandre BOUSSUGE, MD
Contact
alexandre.boussuge@chru-strasbourg.fr
33 3 88 11 54 61
Saïd CHAYER, PhD, HDR
Contact
said.chayer@chru-strasbourg.fr
Alexandre BOUSSUGE, MD
principal investigator · Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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