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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04548908
Other study ID # POCAH-COVID19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 3, 2020
Est. completion date June 30, 2021

Study information

Verified date September 2020
Source Centre Hospitalier Sud Essonne
Contact Delphine LEMAIRE-BRUNEL
Phone 01 60 80 79 88
Email dlemaire-brunel@ch-sudessonne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.


Description:

Since December 2019, the COVID-19 pandemic has widespread from China and put under strong tension the health organizations throughout the world, especially since march 2020 in France.

As a consequence, the French hospitals had to cope with a massive amount of COVID-19 infected patients and, thus, their organisations had to evolve in order to be able to admit more patients in their critical care units.

First studies reported an important level of inter-human contagiousness of the SARS-CoV-2 virus with an "R0" (basic reproduction number) superior to 3, which could lead to a massive contamination of healthcare workers since they are directly in charge of infected patients.

Other studies suggested that the healthcare workers are more likely to be contaminated by the COVID-19 than the rest of the population, which pushed governments and hospital managers to put in place individual and collective measures of protection in order to avoid nosocomial transmissions and also to preserve the health of the hospital staffs in a context of high tension on the hospital work force.

There are today few data about the contamination level among the healthcare workers of general hospitals in France and about the severity of these contaminations. A national study is being conducted but on a macroscopic regional scale. In addition to that, the proportion of asymptomatic SARS-CoV-2 contaminated healthcare workers is not known as well as the origin (hospital or community) of the contaminations.

In June 2020, the French Health Ministry decided to launch a collection of epidemiological data in the French hospitals based on serologic tests. Thanks to this action and with the results of all the RT PCR tests systematically conducted since the beginning of the pandemic when a healthcare worker had COVID-19-like symptoms, the Centre Hospitalier Sud Essonne has decided to conduct an observational study.

The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 1300
Est. completion date June 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- hospital staff working at the Centre Hospitalier Sud Essonne,

- employed by the Centre Hospitalier Sud Essonne between March, 5th, 2020, and August, 31rst, 2020,

- with the result of an RT PCR test or a serologic test,

- this (these) result(s) must have been/be communicated to the occupational health service of the hospital.

Exclusion criteria:

- interim workers,

- workers in holidays during the entire period of inclusion above,

- opposition to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serelogy testing, RT PCR
Serology testing for all the participants and RT PCR for participants with symptoms

Locations

Country Name City State
France Centre Hospitalier Sud Essonne Etampes

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 healthcare workers of the Centre Hospitalier Sud Essonne, defined as the hospital employees with positive serologic or RT-PCR tests.
It must be underlined that the notion of "health workers" include the entire hospital staff ie doctors, nurses, administrative employees,...
Through study completion, an average of 9 months
Secondary Number of asymptomatic healthcare workers no RT PCR or negative RT PCR and positive serologic test,
positive RT PCR and no symptoms,
Through study completion, an average of 9 months
Secondary Number of symptomatic healthcare workers Positive RT-PCR test or serologic test with symptoms. Through study completion, an average of 9 months
Secondary Number of healthcare workers with a severe form of COVID-19 which led to an hospitalization Positive serologic or RTC-PCR test and hospitalization Through study completion, an average of 9 months
Secondary Number of healthcare workers infected with COVID-19 and hospitalized in a critical care unit Positive serologic or RTC-PCR test and hospitalization in a critical care unit Through study completion, an average of 9 months
Secondary Influencing factors of the prevalence of the COVID-19 among healthcare workers age,
gender,
job,
duration of employment in the hospital,
hospital site of affectation,
unit of affectation.
Through study completion, an average of 9 months
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