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

Covid19 Clinical Trial

— SPEED-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04872699
• Other study ID #: SPEED-COVID19
• Status: Recruiting
• Start date: April 22, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Sud Essonne
• Contact: Shidasp SIAMI, MD, PhD
• Phone: 0033 1 60 80 79 40
• Email: ssiami[@]ch-sudessonne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Serology testing, RT PCR
Periodic testings and testings with characteristic symptoms occur

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Essonne	Étampes	Essonne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Essonne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General prevalence of COVID-19	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	Number of asymptomatic residents/inpatients	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
Secondary	Number of symptomatic residents/inpatients	Positive RT-PCR test or serologic test with symptoms	Through study completion, an average of 12 months
Secondary	Number of residents/inpatients with severe form of COVID-19 which led to an hospitalization	Positive RT-PCR test or serologic test and hospitalization	Through study completion, an average of 12 months
Secondary	Number of residents/inpatients infected with COVID-19 and hospitalized in a critical care unit	Positive RT-PCR test or serologic test and hospitalization in critical care unit	Through study completion, an average of 12 months
Secondary	Number of residents/inpatients infected with COVID-19 and deceased	Positive RT-PCR test or serologic test and deceased	Through study completion, an average of 12 months
Secondary	Number of residents/inpatients vaccinated against COVID-19	Positive RT-PCR test or serologic test and vaccinated with any authorized vaccine	Through study completion, an average of 12 months
Secondary	Influencing factors of the prevalence of COVID-19 among residents/inpatients	age; sex; comorbidities; the context of the infection with COVID-19; vaccinated or not	Through study completion, an average of 12 months