Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study (SPEED-COVID)

May 2, 2021 updated by: Centre Hospitalier Sud Essonne
The aim of this study is to evaluate the prevalence of COVID-19 among the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), and the factors that are likely to influence this prevalence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Among people exposed to the COVID-19 (SARS-COV-2) pandemic, elderly people are considered as particularly vulnerable, especially those living in nursing homes or hospitalized. Furthermore, facilities / accommodations are registered among the main locations of COVID-19 clusters.

These observations have led the French government to establish specific protection measures and survey dependent care facilities for the elderly and long-term care units in the hospital.

With these new standards established, a long-term study of all the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), can provide additional knowledge on COVID-19.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Essonne
      • Étampes, Essonne, France, 91150
        • Recruiting
        • Centre Hospitalier Sud Essonne
        • Contact:
        • Principal Investigator:
          • Shidasp SIAMI, MD, PhD
        • Sub-Investigator:
          • Hafida BENHABIB
        • Sub-Investigator:
          • Christine ANDREO
        • Sub-Investigator:
          • El Hadi EL GHOUATI
        • Sub-Investigator:
          • Laurence SAINSARD
        • Sub-Investigator:
          • Christelle APARICIO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), from march, 2020, to december, 2021, who are not opposed to participate in this study.

Description

Inclusion Criteria:

  • residents of the dependant care facility for the elderly
  • inpatients of the long-term care unit
  • from march, 2020 to december, 2021

Exclusion Criteria:

  • opposition to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General prevalence of COVID-19
Time Frame: Through the study completion, an average of 12 months
measures the prevalence of COVID-19 among the residents and geriatric inpatients, defined as resident and patients with positive serologic or RT-PCR test
Through the study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of asymptomatic residents/inpatients
Time Frame: Through study completion, an average of 12 months
  • no RT-PCR test or negative RT-PCR test and positive serologic test,
  • positive RT PCR and no symptoms.
Through study completion, an average of 12 months
Number of symptomatic residents/inpatients
Time Frame: Through study completion, an average of 12 months
Positive RT-PCR test or serologic test with symptoms
Through study completion, an average of 12 months
Number of residents/inpatients with severe form of COVID-19 which led to an hospitalization
Time Frame: Through study completion, an average of 12 months
Positive RT-PCR test or serologic test and hospitalization
Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and hospitalized in a critical care unit
Time Frame: Through study completion, an average of 12 months
Positive RT-PCR test or serologic test and hospitalization in critical care unit
Through study completion, an average of 12 months
Number of residents/inpatients infected with COVID-19 and deceased
Time Frame: Through study completion, an average of 12 months
Positive RT-PCR test or serologic test and deceased
Through study completion, an average of 12 months
Number of residents/inpatients vaccinated against COVID-19
Time Frame: Through study completion, an average of 12 months
Positive RT-PCR test or serologic test and vaccinated with any authorized vaccine
Through study completion, an average of 12 months
Influencing factors of the prevalence of COVID-19 among residents/inpatients
Time Frame: Through study completion, an average of 12 months
  • age
  • sex
  • comorbidities
  • the context of the infection with COVID-19
  • vaccinated or not
Through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Essonne

Investigators

  • Principal Investigator: Shidasp SIAMI, MD, PhD, Centre Hospitalier Sud Essonne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPEED-COVID19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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