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

Study Overview
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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.

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

Conditions
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Sars-CoV2

Intervention / Treatment
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* Diagnostic Test: Anti-SARS-CoV2 Serology
* Other: Questionnaire


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anti-SARS-CoV2 serological status<br>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. | Diagnostic Test: Anti-SARS-CoV2 Serology<br>* 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.<br>Other: Questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-SARS-Cov2 seroconversion between Day 0 and Day 60. | Change of Anti-SARS-Cov2 serological status between Day 0 and Day 60, measured in blood sample. | From Day 0 to Day 60 | 
| Anti-SARS-Cov2 seroconversion between Day 0 and Day 30. | Change of Anti-SARS-Cov2 serological status between Day 0 and Day 30, measured in blood sample. | From Day 0 to Day 30 | 
| Anti-SARS-Cov2 seroconversion between Day 30 and Day 60. | Change of Anti-SARS-Cov2 serological status between Day 30 and Day 60, measured in blood sample. | From Day 30 to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-SARS-Cov2 seroprevalence at Day 0. | Anti-SARS-Cov2 seroprevalence measured in blood sample collected at Day 0. | Day 0 | 
| Correlation between seroconversion and socio-demographic factors - sex | Correlation between seroconversion (measured in blood sample) at Day 60 and sex | Day 60 | 
| Correlation between seroconversion and socio-demographic factors - age | Correlation between seroconversion (measured in blood sample) at Day 60 and age | Day 60 | 
| Correlation between seroconversion and professional factors - job type | Correlation between seroconversion (measured in blood sample) at Day 60 and job type (nurse, physician, etc.) | Day 60 | 
| Correlation between seroconversion and professional factors - personal protective equipment type | Correlation between seroconversion (measured in blood sample) at Day 60 and personal protective equipment type | Day 60 | 
| Correlation between seroconversion and non-professional factors - contact with infected individuals | Correlation between seroconversion (measured in blood sample) at Day 60 and contact with infected individuals | Day 60 | 
| Correlation between seroconversion and non-professional factors - wearing of professional equipment | Correlation between seroconversion (measured in blood sample) at Day 60 and wearing of professional equipment | Day 60 | 
| Correlation between seroconversion and non-professional factors - respect of barrier gestures | Correlation between seroconversion (measured in blood sample) at Day 60 and respect of barrier gestures | Day 60 |