<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/NCT04426292</url>
  </required_header>
  <id_info>
    <org_study_id>COVEMUZ</org_study_id>
    <nct_id>NCT04426292</nct_id>
  </id_info>
  <brief_title>SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak</brief_title>
  <acronym>COVEMUZ</acronym>
  <official_title>SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December&#xD;
      2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus&#xD;
      rapidly spread to the rest of the world, including Europe and explicitly affects the&#xD;
      respiratory system, generating Coronavirus disease 2019 (COVID-19).&#xD;
&#xD;
      This study is a monocentric interventional prospective cohort study. After signing a written&#xD;
      informed consent, participants will be recruited for questionnaire completion and blood&#xD;
      sampling. Sample storage and analysis will be performed at the laboratory of microbiology of&#xD;
      the UZ Brussel.&#xD;
&#xD;
        -  To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e.&#xD;
           at beginning of the study, planned early May 2020), month 2 and month 5.&#xD;
&#xD;
        -  To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over&#xD;
           a period of 5 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Anticipated">December 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 23, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>seroconversions</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of definite cases</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among employees of the UZ Brussel over a period of five months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of probable cases</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document the incidence of new probable cases of COVID-19 (based on study questionnaire) among employees of the UZ Brussel over a period of five months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody kinetics</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document the SARS-CoV-2 antibody kinetics after confirmed and probable COVID-19. Specifically (1) electrostatic interactions, (2) dispersion forces, (3) hydrogen bonds, and (4) hydrophobic interactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential work-related risk factors</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To investigate potential work-related risk factors for SARS-CoV-2 infection among employees of the UZ Brussel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of asymptomatic seroconversions</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To quantify the proportion of asymptomatic seroconversions among employees of the UZ Brussel over a period of five months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concerns for safety for infection with COVID-19</measure>
    <time_frame>Change from baseline to 2 months and 5 months timepoint</time_frame>
    <description>- To document the concerns of HCW and non-HCW about their safety for infection with COVID-19.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3500</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>General arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serological testing</intervention_name>
    <description>Antibody testing for Sars-COV-2 antibodies in blood.</description>
    <arm_group_label>General arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult employee of the UZ Brussel who provided a signed informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  UZ Brussel employees whose contract expires within 6 months of study initiation, with&#xD;
             the exception of resident trainees (if training continues in another hospital,&#xD;
             resident trainees will be asked to perform the last sampling when leaving the UZ&#xD;
             Brussel).&#xD;
&#xD;
          -  Staff not active during the inclusion period&#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_contact>
    <last_name>Sabine Allard, MD</last_name>
    <phone>1923369</phone>
    <email>sabine.allard@uzbrussel.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurien De Greef, Nurse</last_name>
    <phone>1929849</phone>
    <email>laurien.degreef@uzbrussel.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurien De Greef, Nurse</last_name>
      <phone>1929849</phone>
      <email>laurien.degreef@uzbrussel.be</email>
    </contact>
    <investigator>
      <last_name>Sabine Allard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04426292
org study id: COVEMUZ
nct id: NCT04426292
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December
      2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus
      rapidly spread to the rest of the world, including Europe and explicitly affects the
      respiratory system, generating Coronavirus disease 2019 (COVID-19).

      This study is a monocentric interventional prospective cohort study. After signing a written
      informed consent, participants will be recruited for questionnaire completion and blood
      sampling. Sample storage and analysis will be performed at the laboratory of microbiology of
      the UZ Brussel.

        -  To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e.
           at beginning of the study, planned early May 2020), month 2 and month 5.

        -  To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over
           a period of 5 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Seroprevalence
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5.
measure: seroconversions
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.
measure: Incidence of definite cases
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among employees of the UZ Brussel over a period of five months.
measure: Incidence of probable cases
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document the incidence of new probable cases of COVID-19 (based on study questionnaire) among employees of the UZ Brussel over a period of five months.
measure: Antibody kinetics
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document the SARS-CoV-2 antibody kinetics after confirmed and probable COVID-19. Specifically (1) electrostatic interactions, (2) dispersion forces, (3) hydrogen bonds, and (4) hydrophobic interactions.
measure: Potential work-related risk factors
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To investigate potential work-related risk factors for SARS-CoV-2 infection among employees of the UZ Brussel.
measure: Proportion of asymptomatic seroconversions
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To quantify the proportion of asymptomatic seroconversions among employees of the UZ Brussel over a period of five months.
measure: Concerns for safety for infection with COVID-19
time frame: Change from baseline to 2 months and 5 months timepoint
description: - To document the concerns of HCW and non-HCW about their safety for infection with COVID-19.
arm group label: General arm
arm group type: Other
description: All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points
intervention type: Diagnostic Test
intervention name: Serological testing
description: Antibody testing for Sars-COV-2 antibodies in blood.
arm group label: General arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sabine Allard, MD
phone: 1923369
email: sabine.allard@uzbrussel.be
last name: Laurien De Greef, Nurse
phone: 1929849
email: laurien.degreef@uzbrussel.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Undecided