Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

845 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-14

Study Completion Date

2020-08-15

Brief Summary

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Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.

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Detailed Description

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Conditions

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Sars-CoV2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anti-SARS-CoV2 serological status

At Day 0, a blood sample is collected by venipuncture and a questionnaire is being filled. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.

For individuals who are anti-SARS-CoV2 seronegative, the same intervention is made at Day 30 and D60.

For the individuals who are anti-SARS-CoV2 seropositive, the study follow-up is stopped.

Anti-SARS-CoV2 Serology

Intervention Type DIAGNOSTIC_TEST

A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.

Questionnaire

Intervention Type OTHER

Data concerning personal exposure factors are collected in a questionnaire:

* Socio-demographic factors: sex, age
* Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital
* Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures

Interventions

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Anti-SARS-CoV2 Serology

A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.

Intervention Type DIAGNOSTIC_TEST

Questionnaire

Data concerning personal exposure factors are collected in a questionnaire:

* Socio-demographic factors: sex, age
* Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital
* Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Army Training Hospital staff

Exclusion Criteria

* Individuals who have already been confirmed Covid-19 positive
* Individuals taking preventive anti-Covid-19 therapy or considering participating in anti-Covid-19 therapy study
* Individuals on hydroxychloroquine
* Pregnant or breastfeeding women
* Non-permanent staff during the study period
* Individuals identified for a detachment outside the metropole during the study period

Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes