<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/NCT04469647</url>
  </required_header>
  <id_info>
    <org_study_id>IRB20-09</org_study_id>
    <nct_id>NCT04469647</nct_id>
  </id_info>
  <brief_title>COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH</brief_title>
  <official_title>COVID 19 Antibody Seroprevalence Amongst Healthcare Workers in Johns Hopkins Aramco Healthcare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Aramco Healthcare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins Aramco Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthcare workers play a critical role in fighting the pandemic, not only by managing the&#xD;
      patients' health clinically, but also by implementing adequate measures for infection&#xD;
      prevention and control in healthcare facilities. This puts healthcare workers at a greater&#xD;
      risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome&#xD;
      Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and&#xD;
      undetectably.&#xD;
&#xD;
      Serology is an antibody test that provides additional information to polymerase&#xD;
      chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the&#xD;
      population that was infected . Seroconversion is the development of antibodies in the blood&#xD;
      which can confirm suspected cases after the fact and reveal who was infected but asymptomatic&#xD;
      and never realized it. Antibodies are specific proteins created as the body's response to the&#xD;
      infection and this test is essential for detecting infected individuals with few or no&#xD;
      symptoms at all.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">July 19, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2021</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>Seroconversion status</measure>
    <time_frame>6 Months</time_frame>
    <description>Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of asymptomatic infections among staff who have seroconverted</measure>
    <time_frame>6 Months</time_frame>
    <description>Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH</measure>
    <time_frame>6 Months</time_frame>
    <description>To identify the durability of antibody seroconversion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers</measure>
    <time_frame>6 Months</time_frame>
    <description>Age, gender, type of staff, resources</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>High-risk</arm_group_label>
    <description>Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-risk</arm_group_label>
    <description>Employees working at lower risk areas such as (administration, HR, Public relations)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serology Test</intervention_name>
    <description>Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2).&#xD;
at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.</description>
    <arm_group_label>High-risk</arm_group_label>
    <arm_group_label>Low-risk</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare workers, divided into two groups (High-risk and Low-risk).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult.&#xD;
&#xD;
          2. JHAH employee&#xD;
&#xD;
          3. Housekeepers (this group of staff are outsourced at JHAH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Any participant exhibiting COVID 19 symptoms&#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>
  <location>
    <facility>
      <name>Johns Hopkins Aramco Healthcare</name>
      <address>
        <city>Dhahran</city>
        <state>Eastern</state>
        <zip>31311</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations</url>
    <description>Coronavirus disease (COVID-19) technical guidance: The Unity Studies: Early Investigations Protocols</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>SARS-CoV-2</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>Undecided</sharing_ipd>
    <ipd_description>We are willing to share our data after collection de-identified. We plan to share the data with WHO for their unity studies</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 9, 2022</submitted>
    <returned>July 6, 2023</returned>
  </pending_results>
  <!-- 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/NCT04469647
org study id: IRB20-09
nct id: NCT04469647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Healthcare workers play a critical role in fighting the pandemic, not only by managing the
      patients' health clinically, but also by implementing adequate measures for infection
      prevention and control in healthcare facilities. This puts healthcare workers at a greater
      risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome
      Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and
      undetectably.

      Serology is an antibody test that provides additional information to polymerase
      chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the
      population that was infected . Seroconversion is the development of antibodies in the blood
      which can confirm suspected cases after the fact and reveal who was infected but asymptomatic
      and never realized it. Antibodies are specific proteins created as the body's response to the
      infection and this test is essential for detecting infected individuals with few or no
      symptoms at all.
observational model: Cohort
time perspective: Cross-Sectional
measure: Seroconversion status
time frame: 6 Months
description: Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.
measure: The proportion of asymptomatic infections among staff who have seroconverted
time frame: 6 Months
description: Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain)
measure: The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH
time frame: 6 Months
description: To identify the durability of antibody seroconversion
measure: Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers
time frame: 6 Months
description: Age, gender, type of staff, resources
arm group label: High-risk
description: Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers)
arm group label: Low-risk
description: Employees working at lower risk areas such as (administration, HR, Public relations)
intervention type: Diagnostic Test
intervention name: Serology Test
description: Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2).
at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.
arm group label: High-risk
arm group label: Low-risk
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
url: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations
description: Coronavirus disease (COVID-19) technical guidance: The Unity Studies: Early Investigations Protocols
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: We are willing to share our data after collection de-identified. We plan to share the data with WHO for their unity studies
submitted: August 9, 2022
returned: July 6, 2023