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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Procedure: Blood sampling; Procedure: Throat swab

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 417

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bergisch Gladbach, NRW, Germany, 51429
      • Miltenyi Biotec B.V. & Co. KG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Workers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Workers working within a production area	Procedure: Blood sampling; Blood samples; Procedure: Throat swab; Throat swab
Group 2; Workers working within a laboratory area	Procedure: Blood sampling; Blood samples; Procedure: Throat swab; Throat swab
Group 3; Workers working within other areas	Procedure: Blood sampling; Blood samples; Procedure: Throat swab; Throat swab

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Miltenyi Biomedicine GmbH
• Investigators: Principal Investigator: Barbara von Ingersleben, Dr., Miltenyi Biotec B.V. & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: M-2020-360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No