<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/NCT04411576</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19 Studien</org_study_id>
    <nct_id>NCT04411576</nct_id>
  </id_info>
  <brief_title>Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare</brief_title>
  <official_title>Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on&#xD;
      healthcare systems. Little is known about how the infection spreads within healthcare. In&#xD;
      order to design control strategies, knowledge of the presence of viral nucleic acid and&#xD;
      whether an immune response to the virus has been mounted is needed. The purpose of this study&#xD;
      is to determine whether personnel and patients/clients in healthcare in Region Stockholm have&#xD;
      a currrent SARS-CoV-2 infection or have had an infection. This information will be used to&#xD;
      understand how the infection spreads in healthcare, to explore the association with&#xD;
      sick-leave among personnel, and to plan high-quality and safe care.&#xD;
&#xD;
      Healthcare providers and organizations participating in the study from the greater Stockholm&#xD;
      region include the following: Karolinska University Laboratory, Karolinska University&#xD;
      Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal&#xD;
      Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care&#xD;
      Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset);&#xD;
      Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta&#xD;
      Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 infection</measure>
    <time_frame>Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.</time_frame>
    <description>Ongoing and past SARS-CoV-2 infection, measured in throat samples (current infection) and serum (past infection, antibodies to SARS-CoV-2) evaluated in relation to age, gender, sickleave, address, workplace, sampling date, work tasks (for healthcare personnel) and evaluated in relation to date of hospitalization, diagnoses, and interventions for patients and healthcare clients.</description>
  </primary_outcome>
  <other_outcome>
    <measure>SARS-CoV-2 sequencing</measure>
    <time_frame>Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.</time_frame>
    <description>Sequencing will be completed on the positive samples to determine is the virus isolate is the same. This can provide information on the spread of the infection in population.</description>
  </other_outcome>
  <enrollment type="Actual">26326</enrollment>
  <condition>SARS-CoV 2</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Throat swab sample for measuring current infection with SARS-CoV-2</intervention_name>
    <description>Throat sample taken by the study participant to be analyzed with RT PCR for the presence of SARS-CoV-2 viral nucleic acids.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample for serology to measure past infection with SARS-CoV-2</intervention_name>
    <description>Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The throat samples and serum samples collected in this study will be biobanked. Information&#xD;
      on biobanking is included in the informed consent.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare personnel, patients, and clients of healthcare in Stockholm County who do not&#xD;
        have a confirmed or suspected SARS-CoV-2 infection form the study population and are&#xD;
        eligible for inclusion if they fulfill the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (all three criteria must be fulfilled):&#xD;
&#xD;
          -  Healthcare personnel or patient/client of healthcare in Stockholm County&#xD;
&#xD;
          -  Age 18-99&#xD;
&#xD;
          -  Provided consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent to participate provided&#xD;
&#xD;
          -  Already confirmed with SARS-CoV-2 infection&#xD;
&#xD;
          -  Already sampled for SARS-CoV-2 infection based on clinical presention but where the&#xD;
             result has not been reported yet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Joakim Dillner</investigator_full_name>
    <investigator_title>Professor of Infectious Disease Epidemiology; Director of R&amp;D</investigator_title>
  </responsible_party>
  <keyword>Healthcare</keyword>
  <keyword>Personnel</keyword>
  <keyword>Screening</keyword>
  <keyword>Virus</keyword>
  <keyword>Antibodies</keyword>
  <keyword>Sick leave</keyword>
  <keyword>COVID-19</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 have yet to determine whether the IPD will be available for other researchers.</ipd_description>
  </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/NCT04411576
org study id: COVID-19 Studien
nct id: NCT04411576
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on
      healthcare systems. Little is known about how the infection spreads within healthcare. In
      order to design control strategies, knowledge of the presence of viral nucleic acid and
      whether an immune response to the virus has been mounted is needed. The purpose of this study
      is to determine whether personnel and patients/clients in healthcare in Region Stockholm have
      a currrent SARS-CoV-2 infection or have had an infection. This information will be used to
      understand how the infection spreads in healthcare, to explore the association with
      sick-leave among personnel, and to plan high-quality and safe care.

      Healthcare providers and organizations participating in the study from the greater Stockholm
      region include the following: Karolinska University Laboratory, Karolinska University
      Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal
      Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care
      Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset);
      Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta
      Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).
observational model: Cohort
time perspective: Prospective
measure: SARS-CoV-2 infection
time frame: Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.
description: Ongoing and past SARS-CoV-2 infection, measured in throat samples (current infection) and serum (past infection, antibodies to SARS-CoV-2) evaluated in relation to age, gender, sickleave, address, workplace, sampling date, work tasks (for healthcare personnel) and evaluated in relation to date of hospitalization, diagnoses, and interventions for patients and healthcare clients.
measure: SARS-CoV-2 sequencing
time frame: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
description: Sequencing will be completed on the positive samples to determine is the virus isolate is the same. This can provide information on the spread of the infection in population.
intervention type: Diagnostic Test
intervention name: Throat swab sample for measuring current infection with SARS-CoV-2
description: Throat sample taken by the study participant to be analyzed with RT PCR for the presence of SARS-CoV-2 viral nucleic acids.
intervention type: Diagnostic Test
intervention name: Blood sample for serology to measure past infection with SARS-CoV-2
description: Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.
The throat samples and serum samples collected in this study will be biobanked. Information
      on biobanking is included in the informed consent.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Joakim Dillner
investigator title: Professor of Infectious Disease Epidemiology; Director of R&D
mesh term: COVID-19
sharing ipd: Undecided
ipd description: We have yet to determine whether the IPD will be available for other researchers.