<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/NCT04407429</url>
  </required_header>
  <id_info>
    <org_study_id>EK 1387/2020</org_study_id>
    <nct_id>NCT04407429</nct_id>
  </id_info>
  <brief_title>Vienna Versus SARS-CoV-2 Virus Study</brief_title>
  <acronym>VIVI</acronym>
  <official_title>Vienna Versus SARS-CoV-2 Virus: A Prospective Large-scale Antibody Study of SARS-CoV-2 in Patients and Health Care Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients&#xD;
      at the Vienna General Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of 2 parts: a longitudinal study enrolling 3,000 health care&#xD;
      professionals at the Vienna General Hospital testing their antibody status 6 times over a&#xD;
      period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a&#xD;
      total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related&#xD;
      symptoms at 3 different time points during this pandemic (Cohort B).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Anticipated">June 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 27, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of sero-conversion</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of risk markers/factors for SARS-CoV-2 infection</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>SARS-CoV-2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Health care workers</arm_group_label>
    <description>Physicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Laboratory Analyses</intervention_name>
    <description>Storage of serum for SARS-CoV-2-antibodies and biomarkers</description>
    <arm_group_label>Health care workers</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort A: Health care workers&#xD;
&#xD;
        Cohort B: Patients admitted for non-COVID related symptoms&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cohort A:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Physicians&#xD;
&#xD;
          -  Nursing staff&#xD;
&#xD;
          -  Midwives&#xD;
&#xD;
          -  Medical-technical assistants (including medical, therapeutic and diagnostic healthcare&#xD;
             staff, and medical and nursing assistants)&#xD;
&#xD;
          -  Administrative personnel with patient contact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not employed at the Medical University of Vienna or the Vienna General Hospital&#xD;
&#xD;
          -  No signed informed consent&#xD;
&#xD;
        Cohort B:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        ● Patients with available residual serum samples&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ● Serum samples from COVID-19 triage units at the Vienna General Hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Hengstenberg, Univ.-Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Hengstenberg, Univ.-Prof.</last_name>
    <phone>+43 1 40400</phone>
    <phone_ext>46140</phone_ext>
    <email>christian.hengstenberg@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas A Zelniker, DDr.</last_name>
    <phone>+43 1 40400</phone>
    <phone_ext>46140</phone_ext>
    <email>thomas.zelniker@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Hengstenberg, Univ.-Prof.</last_name>
      <phone>+43 1 40400</phone>
      <phone_ext>46140</phone_ext>
      <email>christian.hengstenberg@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Thomas A Zelniker, DDr.</last_name>
      <phone>+43 1 40400</phone>
      <phone_ext>46140</phone_ext>
      <email>thomas.zelniker@meduniwien.ac.at</email>
    </contact_backup>
    <investigator>
      <last_name>Thomas A Zelniker, DDr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniela Gompelmann, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marco Idzko, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Nitsche, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rainer Oberbauer, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Perkmann, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin Riesenhuber, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eva Schernhammer, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tanja Stamm, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Binder, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Christian Hengstenberg</investigator_full_name>
    <investigator_title>Univ.-Prof.</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Immunity</keyword>
  <keyword>Antibodies</keyword>
  <keyword>Virus</keyword>
  <keyword>Respiratory Virus</keyword>
  <keyword>Immunoglobulins</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>
  </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/NCT04407429
org study id: EK 1387/2020
nct id: NCT04407429
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients
      at the Vienna General Hospital.
This study consists of 2 parts: a longitudinal study enrolling 3,000 health care
      professionals at the Vienna General Hospital testing their antibody status 6 times over a
      period of 12 months (Cohort A), and a serial cross-sectional study of 3,000 patients (i.e., a
      total of 9,000 patients) admitted to the Vienna General Hospital for non-COVID-19-related
      symptoms at 3 different time points during this pandemic (Cohort B).
observational model: Cohort
time perspective: Prospective
measure: Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time
time frame: 1 year
measure: Incidence rate of sero-conversion
time frame: 1 year
measure: Identification of risk markers/factors for SARS-CoV-2 infection
time frame: 1 year
arm group label: Health care workers
description: Physicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact
arm group label: Patients
description: Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples.
intervention type: Diagnostic Test
intervention name: Laboratory Analyses
description: Storage of serum for SARS-CoV-2-antibodies and biomarkers
arm group label: Health care workers
arm group label: Patients
Serum samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Hengstenberg, Univ.-Prof.
role: Principal Investigator
affiliation: Medical University of Vienna
last name: Christian Hengstenberg, Univ.-Prof.
phone: +43 1 40400
phone ext: 46140
email: christian.hengstenberg@meduniwien.ac.at
last name: Thomas A Zelniker, DDr.
phone: +43 1 40400
phone ext: 46140
email: thomas.zelniker@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Christian Hengstenberg
investigator title: Univ.-Prof.
mesh term: COVID-19
sharing ipd: Undecided