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.
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.
Procedure: Blood sampling
Blood samples
Procedure: Throat swab
Throat swab
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
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach, NRW, Germany
Barbara von Ingersleben, Dr., Principal Investigator
Miltenyi Biotec B.V. & Co. KG