A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers

Study Overview
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Brief Summary
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This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.

Detailed Description
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This study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic infected persons. In total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. There will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3). The fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. For each timepoint the difference between the cohorts is investigated. This study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation. Epidemiological exposure data and biological samples will be systematically collected. The present study is being conducted in line with World Health Organization recommendations to help understanding the epidemiology of SARS-Cov-2.

Official Title
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A Prospective, Epidemiological, Cohort Study to Assess the Feasibility of Screening Healthy Asymptomatic Workers for the Presence of SARS-CoV-2 by Pharyngeal Swaps and Serology at Baseline, Day 21 and Day 40

Conditions
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COVID-19

Intervention / Treatment
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* Procedure: Blood sampling
* Procedure: Throat swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy workers asymptomatic for SARS-CoV-2 Ability to consent with the study and its procedures Age above 18 years old Full time employee on site at least 3 full working days a week Working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas. Exclusion Criteria: Workers presenting symptoms that could be signs of a SARS-CoV-2 infection such as: fever ≥38°C chills fatigue muscle ache (myalgia) sore throat cough runny nose (rhinorrhea) shortness of breath (dyspnea) wheezing chest pain other respiratory Symptoms headache nausea/vomiting

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Group 1<br>Workers working within a production area | Procedure: Blood sampling<br>* Blood samples<br>Procedure: Throat swab<br>* Throat swab<br>|
| Group 2<br>Workers working within a laboratory area | Procedure: Blood sampling<br>* Blood samples<br>Procedure: Throat swab<br>* Throat swab<br>|
| Group 3<br>Workers working within other areas | Procedure: Blood sampling<br>* Blood samples<br>Procedure: Throat swab<br>* Throat swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune responses to components of SARS-Cov-2 | Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. Analysis of trends in CD4/CD8 concentrations over time and correlation with immunoglobulin G (IgG) Levels and new assay evaluation. | up to visit 3 (day 40) | 
| Swabs for the presence of SARSCoV-2 | Evaluation of Swab for the presence of SARS-CoV-2 by PCR and determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. | up to visit 3 (day 40) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the study groups in anti-SARS-CoV 2 seropositivity status | Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status and analysis of trends in CD4/CD8 concentrations over time and correlation with IgG Levels as well as new assay evaluation. | up to visit 3 (day 40) |