NCT05085522

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

December 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

October 7, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

COVID-19RT-PCRSARS-CoV-2

Outcome Measures

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

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alexandre BOUSSUGE, MD

    Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

August 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

December 1, 2021

Record last verified: 2021-10

Locations