Clinical trial NCT04405466: A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Miltenyi Biomedicine GmbH
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Workers

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immune responses to components of SARS-Cov-2
timeFrame: up to visit 3 (day 40)
measure: Swabs for the presence of SARSCoV-2
timeFrame: up to visit 3 (day 40)
Secondary outcomes:
measure: Difference between the study groups in anti-SARS-CoV 2 seropositivity status
timeFrame: up to visit 3 (day 40)
Other outcomes:
Locations:
city: Bergisch Gladbach
country: Germany
facility: Miltenyi Biotec B.V. & Co. KG
state: NRW
Study officials:
affiliation: Miltenyi Biotec B.V. & Co. KG
name: Barbara von Ingersleben, Dr.
role: PRINCIPAL_INVESTIGATOR
References: