<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/NCT04424017</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19\004</org_study_id>
    <nct_id>NCT04424017</nct_id>
  </id_info>
  <brief_title>Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers</brief_title>
  <official_title>Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Egyptian Center for Research and Regenerative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Centre, Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academy of Scientific Research and Technology, Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Egyptian Center for Research and Regenerative Medicine</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>
      The medical and paramedical staff of the front-line services are potentially exposed to&#xD;
      SARS-CoV-2. Therefore, despite the application of standard protective measures, it is&#xD;
      possible that a certain number of these personnel have already contracted SARS-CoV-2,&#xD;
      including in its asymptomatic form. Serological testing in this context would be useful for&#xD;
      deploying immune healthcare workers as to limit the risk of viral infection and transmission.&#xD;
      Therefore, it is of utmost importance to prove that the serological response entails the&#xD;
      production of neutralizing antibodies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1546</enrollment>
  <condition>COVID</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Healthcare workers (HCWs)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy blood donors and healthy subjects in blood bank</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Convalescents</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Specific anti-SARS-CoV-2 antibodies</intervention_name>
    <description>A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.&#xD;
All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).</description>
    <arm_group_label>Convalescents</arm_group_label>
    <arm_group_label>Healthcare workers (HCWs)</arm_group_label>
    <arm_group_label>Healthy blood donors and healthy subjects in blood bank</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Age-stratified sample from general population with 3 subgroups:&#xD;
&#xD;
          1. Healthcare workers (HCWs), comprising frontline doctors, nurses, health attendants,&#xD;
             and receptionists.&#xD;
&#xD;
          2. Healthy blood donors and healthy subjects in blood bank or laboratory (routine&#xD;
             examinations as pre-employment, likely to be representative of the general population&#xD;
&#xD;
          3. Convalescents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not previously diagnosed with COVID-19 except for convalescents&#xD;
&#xD;
          -  Not currently symptomatic with fever or respiratory symptoms (cough, dyspnea)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with fever or respiratory symptoms (cough, dyspnea)&#xD;
&#xD;
          -  Refusal to give informed consent, or contraindication to venipuncture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ECRRM</name>
      <address>
        <city>Cairo</city>
        <zip>32</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine, Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 7, 2021</last_update_submitted>
  <last_update_submitted_qc>March 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <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/NCT04424017
org study id: COVID-19\004
nct id: NCT04424017
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The medical and paramedical staff of the front-line services are potentially exposed to
      SARS-CoV-2. Therefore, despite the application of standard protective measures, it is
      possible that a certain number of these personnel have already contracted SARS-CoV-2,
      including in its asymptomatic form. Serological testing in this context would be useful for
      deploying immune healthcare workers as to limit the risk of viral infection and transmission.
      Therefore, it is of utmost importance to prove that the serological response entails the
      production of neutralizing antibodies.
observational model: Other
time perspective: Cross-Sectional
measure: Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies
time frame: 3 Months
arm group label: Healthcare workers (HCWs)
arm group label: Healthy blood donors and healthy subjects in blood bank
arm group label: Convalescents
intervention type: Biological
intervention name: Specific anti-SARS-CoV-2 antibodies
description: A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.
All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).
arm group label: Convalescents
arm group label: Healthcare workers (HCWs)
arm group label: Healthy blood donors and healthy subjects in blood bank
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: No