<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04405466</url>
  </required_header>
  <id_info>
    <org_study_id>M-2020-360</org_study_id>
    <nct_id>NCT04405466</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miltenyi Biomedicine GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miltenyi Biomedicine GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, epidemiological, cohort study to assess the feasibility of screening&#xD;
      healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2&#xD;
      by pharyngeal swaps and serology at baseline, day 21 and day 40.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been designed to assess the feasibility of screening asymptomatic workers and&#xD;
      to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune&#xD;
      response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the&#xD;
      extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as&#xD;
      the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic&#xD;
      infected persons.&#xD;
&#xD;
      In total, approximately up to 500 workers will be enrolled into the trial to have 450&#xD;
      evaluable subjects at the end of the study. There will be three individual cohorts of workers&#xD;
      working in different departments: workers from the production area (cohort 1), workers from&#xD;
      the laboratory area (cohort 2) and workers working in other areas (cohort 3).&#xD;
&#xD;
      The fraction of asymptomatic or subclinical infections should be determined as well as the&#xD;
      kinetics of the immune responses. For each timepoint the difference between the cohorts is&#xD;
      investigated. This study also aims to evaluate the impact of sanitary and preventive measures&#xD;
      taken within the company during the pandemic situation.&#xD;
&#xD;
      Epidemiological exposure data and biological samples will be systematically collected. The&#xD;
      present study is being conducted in line with World Health Organization recommendations to&#xD;
      help understanding the epidemiology of SARS-Cov-2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 22, 2020</start_date>
  <completion_date type="Actual">December 17, 2020</completion_date>
  <primary_completion_date type="Actual">November 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune responses to components of SARS-Cov-2</measure>
    <time_frame>up to visit 3 (day 40)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Swabs for the presence of SARSCoV-2</measure>
    <time_frame>up to visit 3 (day 40)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between the study groups in anti-SARS-CoV 2 seropositivity status</measure>
    <time_frame>up to visit 3 (day 40)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">417</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Workers working within a production area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Workers working within a laboratory area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Workers working within other areas</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood samples</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Throat swab</intervention_name>
    <description>Throat swab</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples, throat swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Workers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy workers asymptomatic for SARS-CoV-2&#xD;
&#xD;
          -  Ability to consent with the study and its procedures&#xD;
&#xD;
          -  Age above 18 years old&#xD;
&#xD;
          -  Full time employee on site at least 3 full working days a week&#xD;
&#xD;
          -  Working in a shared office/lab/manufacturing environment where at least 3 employees&#xD;
             are present and/or having frequent contact with others i.e reception area,&#xD;
             transportation and delivery areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Workers presenting symptoms that could be signs of a SARS-CoV-2 infection such as:&#xD;
&#xD;
          -  fever ≥38°C&#xD;
&#xD;
          -  chills&#xD;
&#xD;
          -  fatigue&#xD;
&#xD;
          -  muscle ache (myalgia)&#xD;
&#xD;
          -  sore throat&#xD;
&#xD;
          -  cough&#xD;
&#xD;
          -  runny nose (rhinorrhea)&#xD;
&#xD;
          -  shortness of breath (dyspnea)&#xD;
&#xD;
          -  wheezing&#xD;
&#xD;
          -  chest pain&#xD;
&#xD;
          -  other respiratory Symptoms&#xD;
&#xD;
          -  headache&#xD;
&#xD;
          -  nausea/vomiting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara von Ingersleben, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miltenyi Biotec B.V. &amp; Co. KG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miltenyi Biotec B.V. &amp; Co. KG</name>
      <address>
        <city>Bergisch Gladbach</city>
        <state>NRW</state>
        <zip>51429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405466
org study id: M-2020-360
nct id: NCT04405466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Immune responses to components of SARS-Cov-2
time frame: up to visit 3 (day 40)
description: 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.
measure: Swabs for the presence of SARSCoV-2
time frame: up to visit 3 (day 40)
description: 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.
measure: Difference between the study groups in anti-SARS-CoV 2 seropositivity status
time frame: up to visit 3 (day 40)
description: 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.
arm group label: Group 1
description: Workers working within a production area
arm group label: Group 2
description: Workers working within a laboratory area
arm group label: Group 3
description: Workers working within other areas
intervention type: Procedure
intervention name: Blood sampling
description: Blood samples
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Procedure
intervention name: Throat swab
description: Throat swab
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
Blood samples, throat swab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara von Ingersleben, Dr.
role: Principal Investigator
affiliation: Miltenyi Biotec B.V. & Co. KG
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No