<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/NCT04425889</url>
  </required_header>
  <id_info>
    <org_study_id>IF20-00008</org_study_id>
    <nct_id>NCT04425889</nct_id>
  </id_info>
  <brief_title>COVID-19 Antibodies Among Healthcare Workers</brief_title>
  <official_title>Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</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>
      Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14&#xD;
      days or more had passed from their first entrance to contaminated areas were included. They&#xD;
      were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used&#xD;
      for antibody detection, and selected participants were subject to real time polymerase chain&#xD;
      reaction (qPCR) for SARS-CoV-2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of antibody</measure>
    <time_frame>through study completion, an average of 8 weeks</time_frame>
    <description>presence of IgG and/or IgM against SARS-CoV-2</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">156</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>exposed Healthcare workers</arm_group_label>
    <description>Healthcare workers working for 8 weeks in a COVID-19 area</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)</intervention_name>
    <description>a blood sample is drained for detection of IgG and IgM antibody</description>
    <arm_group_label>exposed Healthcare workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare workes of any category that are 18 years of age or older, who work in the&#xD;
        COVID-19 unit at the University Hospital and hve been diagnosing and treating suspected or&#xD;
        confirmed cases of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All healthcare workers who had entered contaminated areas at least once and that 14&#xD;
             days or more had passed from their first entrance were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthcare workers who did not have exposure for more or equal 14 days&#xD;
&#xD;
          -  Healthcare workers who did not wish to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario José E. Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 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>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>Dr. Adrian Camacho-Ortiz</investigator_full_name>
    <investigator_title>Head of infectious diseases</investigator_title>
  </responsible_party>
  <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>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/NCT04425889
org study id: IF20-00008
nct id: NCT04425889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody
All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14
      days or more had passed from their first entrance to contaminated areas were included. They
      were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used
      for antibody detection, and selected participants were subject to real time polymerase chain
      reaction (qPCR) for SARS-CoV-2.
observational model: Cohort
time perspective: Cross-Sectional
measure: Presence of antibody
time frame: through study completion, an average of 8 weeks
description: presence of IgG and/or IgM against SARS-CoV-2
arm group label: exposed Healthcare workers
description: Healthcare workers working for 8 weeks in a COVID-19 area
intervention type: Diagnostic Test
intervention name: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)
description: a blood sample is drained for detection of IgG and IgM antibody
arm group label: exposed Healthcare workers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: Dr. Adrian Camacho-Ortiz
investigator title: Head of infectious diseases
mesh term: COVID-19
sharing ipd: Undecided