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NCT Number: NCT04405466

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miltenyi Biotec B.V. & Co. KG

Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

Blood samples

Throat swab

Procedure

Throat swab

Primary outcomes

  1. Immune responses to components of SARS-Cov-2

    Time frame: up to visit 3 (day 40)

    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.

  2. Swabs for the presence of SARSCoV-2

    Time frame: up to visit 3 (day 40)

    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.

Secondary outcomes

  1. Difference between the study groups in anti-SARS-CoV 2 seropositivity status

    Time frame: up to visit 3 (day 40)

    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.

Sponsors and collaborators

Lead sponsor

Miltenyi Biomedicine GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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