<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/NCT04503447</url>
  </required_header>
  <id_info>
    <org_study_id>SARSCOV2SEROPREVALENCEITMSTAFF</org_study_id>
    <nct_id>NCT04503447</nct_id>
  </id_info>
  <brief_title>COVID-19 Seroprevalence Study in ITM Staff</brief_title>
  <acronym>CovAb</acronym>
  <official_title>Severe Acute Respiratory Syndrome Coronavirus (CoV) 2 (SARS-CoV-2) Seroprevalence Study in Institute of Tropical Medicine (ITM) Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Tropical Medicine, Belgium</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>
      In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its&#xD;
      second wave.&#xD;
&#xD;
      The Belgian crisis cell is balancing between allowing the economy to recover and minimize the&#xD;
      disease spread. To decide which containment measures should be maintained, reinstalled or&#xD;
      suspended, information on what proportion of people has been infected and on possible risk&#xD;
      factors for virus transmission can be helpful.&#xD;
&#xD;
      This study will be conducted on staff members of the ITM. All staff members will be invited&#xD;
      to participate. Participants will be asked to have a blood sample drawn for detections of&#xD;
      antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2&#xD;
      ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to&#xD;
      complete a questionnaire about their exposure, both within and outside the ITM, to the&#xD;
      SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the&#xD;
      occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary&#xD;
      objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified&#xD;
      by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to&#xD;
      COVID-19 patients/samples, comorbidities, adherence to containment measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is observational and will be conducted on ITM staff members. All members will be&#xD;
      invited to participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">September 9, 2020</completion_date>
  <primary_completion_date type="Actual">September 9, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 seroprevalence ITM staff</measure>
    <time_frame>Sample is drawn once, within 7 days after recruitment</time_frame>
    <description>The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 seroprevalence in ITM staff, stratified by variables</measure>
    <time_frame>Questionnaire is completed once, at recruitment</time_frame>
    <description>SARS-CoV-2 seroprevalence in ITM staff members stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk or protective factors for SARS-CoV-2 seropositivity</measure>
    <time_frame>Questionnaire is completed once, at recruitment</time_frame>
    <description>To identify factors that are associated with an elevated or reduced risk of seropositivity in ITM staff and the Belgian working population in general.</description>
  </other_outcome>
  <enrollment type="Actual">330</enrollment>
  <condition>Covid19</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Active ITM staff members&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be an active ITM staff member&#xD;
&#xD;
          -  Be willing and able to complete the questionnaire&#xD;
&#xD;
          -  Be willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Doctor of Philosophy (PhD) students, Master students and interns of the ITM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Marjan Van Esbroeck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Tropical Medicine, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Tropical Medicine</name>
      <address>
        <city>Antwerp</city>
        <zip>2000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>humans</keyword>
  <keyword>COVID-19</keyword>
  <keyword>pandemics</keyword>
  <keyword>SARS virus</keyword>
  <keyword>cross-sectional studies</keyword>
  <keyword>seroepidemiological studies</keyword>
  <keyword>Belgium</keyword>
  <keyword>risk factors</keyword>
  <keyword>seroprevalence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Study population being only ITM staff members, individual participant data (IPD) cannot be shared due to privacy reasons</ipd_description>
  </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/NCT04503447
org study id: SARSCOV2SEROPREVALENCEITMSTAFF
nct id: NCT04503447
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its
      second wave.

      The Belgian crisis cell is balancing between allowing the economy to recover and minimize the
      disease spread. To decide which containment measures should be maintained, reinstalled or
      suspended, information on what proportion of people has been infected and on possible risk
      factors for virus transmission can be helpful.

      This study will be conducted on staff members of the ITM. All staff members will be invited
      to participate. Participants will be asked to have a blood sample drawn for detections of
      antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2
      ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to
      complete a questionnaire about their exposure, both within and outside the ITM, to the
      SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the
      occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary
      objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified
      by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to
      COVID-19 patients/samples, comorbidities, adherence to containment measures.
The study is observational and will be conducted on ITM staff members. All members will be
      invited to participate.
observational model: Other
time perspective: Cross-Sectional
measure: SARS-CoV-2 seroprevalence ITM staff
time frame: Sample is drawn once, within 7 days after recruitment
description: The proportion of participating ITM staff members with detectable SARS-CoV-2 antibodies
measure: SARS-CoV-2 seroprevalence in ITM staff, stratified by variables
time frame: Questionnaire is completed once, at recruitment
description: SARS-CoV-2 seroprevalence in ITM staff members stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.
measure: Risk or protective factors for SARS-CoV-2 seropositivity
time frame: Questionnaire is completed once, at recruitment
description: To identify factors that are associated with an elevated or reduced risk of seropositivity in ITM staff and the Belgian working population in general.
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Marjan Van Esbroeck, MD
role: Principal Investigator
affiliation: Institute of Tropical Medicine, Belgium
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: Study population being only ITM staff members, individual participant data (IPD) cannot be shared due to privacy reasons