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

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

417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2020-12-17

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.

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Workers working within a production area

Blood sampling

Intervention Type PROCEDURE

Blood samples

Throat swab

Intervention Type PROCEDURE

Throat swab

Group 2

Workers working within a laboratory area

Blood sampling

Intervention Type PROCEDURE

Blood samples

Throat swab

Intervention Type PROCEDURE

Throat swab

Group 3

Workers working within other areas

Blood sampling

Intervention Type PROCEDURE

Blood samples

Throat swab

Intervention Type PROCEDURE

Throat swab

Interventions

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Blood sampling

Blood samples

Intervention Type PROCEDURE

Throat swab

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes