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

NCT04405466 | Completed

• 1 other identifier: M-2020-360
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  up to visit 3 (day 40)

Study Arms (3)

Group 1

Workers working within a production area

Procedure: Blood sampling; Procedure: Throat swab

Group 2

Workers working within a laboratory area

Procedure: Blood sampling; Procedure: Throat swab

Group 3

Workers working within other areas

Procedure: Blood sampling; Procedure: Throat swab

Interventions

Blood sampling PROCEDURE

Blood samples

Group 1; Group 2; Group 3

Throat swab PROCEDURE

Throat swab

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Workers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH: lead

Study Sites (1)

Miltenyi Biotec B.V. & Co. KG

Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, throat swab

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Barbara von Ingersleben, Dr.

  Miltenyi Biotec B.V. & Co. KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 28, 2020
• Study Start: April 22, 2020
• Primary Completion: November 5, 2020
• Study Completion: December 17, 2020
• Last Updated: May 25, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)