<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/NCT04446338</url>
  </required_header>
  <id_info>
    <org_study_id>292/2020BO2</org_study_id>
    <nct_id>NCT04446338</nct_id>
  </id_info>
  <brief_title>Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre</brief_title>
  <acronym>CovidImmunEye</acronym>
  <official_title>Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The&#xD;
      protocol included a rapid test and several ELISA tests within a defined cohort of healthcare&#xD;
      workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current pandemic, the assessment of actual COVID-19 infections plays an important role&#xD;
      in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid&#xD;
      tests will be available, the aim of which is to be able to obtain a good overview of the&#xD;
      immune status of corresponding samples in a timely manner.&#xD;
&#xD;
      Employees in the health sector are faced with additional challenges, not only due to the&#xD;
      tightened hygiene regulations. The concern about infecting other people and/or exposing&#xD;
      oneself to a relevant health risk is of great importance. A moderate to high transmission&#xD;
      risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable&#xD;
      proximity, targeted and reliable diagnostics can offer the potential to reduce the risk&#xD;
      potential for the current situation by determining antibodies.&#xD;
&#xD;
      A rapid diagnosis is not yet available outside of clinical studies, especially since deficits&#xD;
      in specificity (contact with other coronaviruses) are to be expected. Studies on the&#xD;
      serological reaction are not yet available for longer observation periods, but it can be&#xD;
      assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available&#xD;
      at the latest 3 weeks after the onset of symptoms. Without larger and representative&#xD;
      analyses, it is currently unclear whether seroconversion is associated with permanent&#xD;
      immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test&#xD;
      procedure is therefore to be offered to employees within the framework of a random sample.&#xD;
&#xD;
      The query of anamnestic parameters allows the assignment to different groups (CC: past COVID&#xD;
      infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is&#xD;
      to provide a first preliminary evaluation of the tests used in the current context.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence</measure>
    <time_frame>through study completion, maximum of one year</time_frame>
    <description>Rate of anti-SARS-CoV-2 Antibodies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Agreement of the test results and questionnaire</measure>
    <time_frame>through study completion, maximum of one year</time_frame>
    <description>Kappa statistics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive / negative values of the tests applied</measure>
    <time_frame>through study completion, maximum of one year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>History of Covid-19, Seroprevalence</condition>
  <arm_group>
    <arm_group_label>Healthcare Worker</arm_group_label>
    <description>Staff of the Department of Ophthalmology, University Tuebingen, Germany</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Antibody Test</intervention_name>
    <description>Presence and Titer of Anti-Sars-CoV-2 Antbodies</description>
    <arm_group_label>Healthcare Worker</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Employee of the Department of Ophthalmology (at a university institution)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employees of the health facility described&#xD;
&#xD;
          -  voluntary request for testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#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_contact>
    <last_name>Focke Ziemssen, MD</last_name>
    <phone>+49 7071 29 88088</phone>
    <email>focke.ziemssen@med.uni-tuebingen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tarek Bayyoud, MD</last_name>
    <phone>+49 7071 29 88088</phone>
    <email>tarek.bayyoud@med.uni-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>BW</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Focke Ziemssen</last_name>
      <phone>+49 7071 29 88088</phone>
      <email>focke.ziemssen@med.uni-tuebingen.de</email>
    </contact>
    <investigator>
      <last_name>Focke Ziemssen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tarek Bayyoud, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seroprevalence</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04446338
org study id: 292/2020BO2
nct id: NCT04446338
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The
      protocol included a rapid test and several ELISA tests within a defined cohort of healthcare
      workers.
In the current pandemic, the assessment of actual COVID-19 infections plays an important role
      in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid
      tests will be available, the aim of which is to be able to obtain a good overview of the
      immune status of corresponding samples in a timely manner.

      Employees in the health sector are faced with additional challenges, not only due to the
      tightened hygiene regulations. The concern about infecting other people and/or exposing
      oneself to a relevant health risk is of great importance. A moderate to high transmission
      risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable
      proximity, targeted and reliable diagnostics can offer the potential to reduce the risk
      potential for the current situation by determining antibodies.

      A rapid diagnosis is not yet available outside of clinical studies, especially since deficits
      in specificity (contact with other coronaviruses) are to be expected. Studies on the
      serological reaction are not yet available for longer observation periods, but it can be
      assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available
      at the latest 3 weeks after the onset of symptoms. Without larger and representative
      analyses, it is currently unclear whether seroconversion is associated with permanent
      immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test
      procedure is therefore to be offered to employees within the framework of a random sample.

      The query of anamnestic parameters allows the assignment to different groups (CC: past COVID
      infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is
      to provide a first preliminary evaluation of the tests used in the current context.
observational model: Cohort
time perspective: Prospective
measure: Seroprevalence
time frame: through study completion, maximum of one year
description: Rate of anti-SARS-CoV-2 Antibodies
measure: Agreement of the test results and questionnaire
time frame: through study completion, maximum of one year
description: Kappa statistics
measure: Positive predictive / negative values of the tests applied
time frame: through study completion, maximum of one year
arm group label: Healthcare Worker
description: Staff of the Department of Ophthalmology, University Tuebingen, Germany
intervention type: Diagnostic Test
intervention name: Antibody Test
description: Presence and Titer of Anti-Sars-CoV-2 Antbodies
arm group label: Healthcare Worker
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Focke Ziemssen, MD
phone: +49 7071 29 88088
email: focke.ziemssen@med.uni-tuebingen.de
last name: Tarek Bayyoud, MD
phone: +49 7071 29 88088
email: tarek.bayyoud@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: No