<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/NCT04444596</url>
  </required_header>
  <id_info>
    <org_study_id>1104/2020</org_study_id>
    <nct_id>NCT04444596</nct_id>
  </id_info>
  <brief_title>Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19</brief_title>
  <official_title>Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</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 possible study is to identify if SARS-CoV-2 can be found in the tear film and&#xD;
      conjunctiva of a patient with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV2 positive conjunctival swabs</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conjunctival swab vs nasopharyngeal swab</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Viability of SARS-COV 2</measure>
    <time_frame>1 year</time_frame>
    <description>In the case of a SARS-COV 2 positive conjunctival swab a virus culture will be conducted to clarify, whether it is a viable virus or virus RNA fragments.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Swab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conjunctival swab and nasopharyngeal swab for SARS-COV 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Conjunctival swab and nasopharyngeal swab</intervention_name>
    <description>Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.</description>
    <arm_group_label>Swab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  A confirmed COVID-19 disease&#xD;
&#xD;
          -  Signed and dated declaration of consent&#xD;
&#xD;
          -  The patient fell ill in Tyrol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teresa Rauchegger, Dr.</last_name>
      <phone>0043 504 24184</phone>
      <email>teresa.rauchegger@i-med.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Claus Zehetner, Dr.</last_name>
      <phone>0043 504 24184</phone>
      <email>claus.zehetner@i-med.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT04444596
org study id: 1104/2020
nct id: NCT04444596
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this possible study is to identify if SARS-CoV-2 can be found in the tear film and
      conjunctiva of a patient with COVID-19.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SARS-CoV2 positive conjunctival swabs
time frame: 1 year
description: The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2.
measure: Conjunctival swab vs nasopharyngeal swab
time frame: 1 year
description: The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab.
measure: Viability of SARS-COV 2
time frame: 1 year
description: In the case of a SARS-COV 2 positive conjunctival swab a virus culture will be conducted to clarify, whether it is a viable virus or virus RNA fragments.
arm group label: Swab
arm group type: Other
description: Conjunctival swab and nasopharyngeal swab for SARS-COV 2
intervention type: Diagnostic Test
intervention name: Conjunctival swab and nasopharyngeal swab
description: Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.
arm group label: Swab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No