COVID-19 Clinical Trial
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
NCT number | NCT04405466 |
Other study ID # | M-2020-360 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 22, 2020 |
Est. completion date | December 17, 2020 |
Verified date | July 2020 |
Source | Miltenyi Biomedicine GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 417 |
Est. completion date | December 17, 2020 |
Est. primary completion date | November 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Miltenyi Biotec B.V. & Co. KG | Bergisch Gladbach | NRW |
Lead Sponsor | Collaborator |
---|---|
Miltenyi Biomedicine GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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) |
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