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

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Miltenyi Biomedicine GmbH
Updated on 19 February 2024
covid-19
SARS
throat
acute respiratory syndrome (sars)

Summary

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.

Description

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.

Details
Condition Covid 19
Age 18-100 years
Treatment blood sampling, Throat swab
Clinical Study IdentifierNCT04405466
SponsorMiltenyi Biomedicine GmbH
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 38C
chills
fatigue
muscle ache (myalgia)
sore throat
cough
runny nose (rhinorrhea)
shortness of breath (dyspnea)
wheezing
chest pain
other respiratory Symptoms
headache
nausea/vomiting
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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