<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/NCT04431310</url>
  </required_header>
  <id_info>
    <org_study_id>Journal-nr.: H-20022312</org_study_id>
    <nct_id>NCT04431310</nct_id>
  </id_info>
  <brief_title>Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic</brief_title>
  <official_title>Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nykøbing Falster County Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nordsjaellands Hospital</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 aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in&#xD;
      samples collected from HCWs in an acute hospital. This will enable the identification of&#xD;
      those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and&#xD;
      therefore potentially susceptible and infectious on patient contact. Prospective testing will&#xD;
      provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk&#xD;
      factors for transmission during a pandemic at an acute care hospital facility in the capital&#xD;
      region of Denmark.&#xD;
&#xD;
      Hypothesis: Serial seroconversion measurements in hospital employees improve the organization&#xD;
      of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and&#xD;
      Nykøbing Falster County Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the&#xD;
      second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators&#xD;
      in United Kingdom for antibody analyses during the course of the local epidemic, expected to&#xD;
      last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly&#xD;
      intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity&#xD;
      of SARS-CoV-2 infection up to 5 years post-pandemic.&#xD;
&#xD;
      Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and&#xD;
      few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all&#xD;
      departments with staff that are in physical contact with patients during the pandemic will be&#xD;
      invited to participate in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serology testing for specific COVID-19</measure>
    <time_frame>From baseline to follow up at four years</time_frame>
    <description>IgM and IgG (Covid-19 antibodies)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 infection</measure>
    <time_frame>From baseline to follow up at three months</time_frame>
    <description>Swab, SARS-CoV-2</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Co-variates</measure>
    <time_frame>At baseline</time_frame>
    <description>Age, gender, employment details, smoking, chronic diseases</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Covid-19</condition>
  <condition>Health Personnel</condition>
  <condition>Personnel, Hospital</condition>
  <arm_group>
    <arm_group_label>Serial seroconversion measurements in hospital employees</arm_group_label>
    <description>Serial seroconversion measurements in hospital employees during the COVID-19 pandemic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serial seroconversion measurements in hospital employees during the COVID-19 pandemic</intervention_name>
    <description>The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.</description>
    <arm_group_label>Serial seroconversion measurements in hospital employees</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Full blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Health care workers at two Danish hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: hospital employee&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: none&#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_official>
    <last_name>Thea K Fischer, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nordsjællands Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fischer</last_name>
    <phone>+45 2440 1718</phone>
    <email>thea.koelsen.fischer@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nordsjællands Hospital</name>
      <address>
        <city>Hillerød</city>
        <state>Capital Region</state>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thea K Fischer</last_name>
      <phone>+45 2440 1718</phone>
      <email>thea.koelsen.fischer@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nykøbing Falster County Hospital</name>
      <address>
        <city>Nykøbing Falster</city>
        <state>Southern Region</state>
        <zip>4800</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gry St-Martin, md</last_name>
      <phone>+45 20537137</phone>
      <email>grys@regionsjaelland.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
    <investigator_full_name>Thea Kølsen Fischer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>healthcare workers</keyword>
  <keyword>health care workers</keyword>
  <keyword>hcw</keyword>
  <keyword>seroconversion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04431310
org study id: Journal-nr.: H-20022312
nct id: NCT04431310
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in
      samples collected from HCWs in an acute hospital. This will enable the identification of
      those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and
      therefore potentially susceptible and infectious on patient contact. Prospective testing will
      provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk
      factors for transmission during a pandemic at an acute care hospital facility in the capital
      region of Denmark.

      Hypothesis: Serial seroconversion measurements in hospital employees improve the organization
      of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and
      Nykøbing Falster County Hospital.
The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the
      second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators
      in United Kingdom for antibody analyses during the course of the local epidemic, expected to
      last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly
      intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity
      of SARS-CoV-2 infection up to 5 years post-pandemic.

      Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and
      few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all
      departments with staff that are in physical contact with patients during the pandemic will be
      invited to participate in the study.
observational model: Cohort
time perspective: Prospective
measure: Serology testing for specific COVID-19
time frame: From baseline to follow up at four years
description: IgM and IgG (Covid-19 antibodies)
measure: SARS-CoV-2 infection
time frame: From baseline to follow up at three months
description: Swab, SARS-CoV-2
measure: Co-variates
time frame: At baseline
description: Age, gender, employment details, smoking, chronic diseases
arm group label: Serial seroconversion measurements in hospital employees
description: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic
intervention type: Other
intervention name: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic
description: The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.
arm group label: Serial seroconversion measurements in hospital employees
Full blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thea K Fischer, professor
role: Principal Investigator
affiliation: Nordsjællands Hospital
last name: Fischer
phone: +45 2440 1718
email: thea.koelsen.fischer@regionh.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Nordsjaellands Hospital
investigator full name: Thea Kølsen Fischer
investigator title: Professor
mesh term: COVID-19