<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/NCT04424849</url>
  </required_header>
  <id_info>
    <org_study_id>2020/5-4</org_study_id>
    <nct_id>NCT04424849</nct_id>
  </id_info>
  <brief_title>Thorax Computed Tomography Severity Score and Outcome in COVID-19 Patients</brief_title>
  <official_title>Initial Thoracic CT Findings and Mechanical Ventilation Requirement in Patients Admitted to Intensive Care Unit With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tepecik Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tepecik Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most common thorax Computed tomography (CT) findings are multifocal ground-glass&#xD;
      opacities and peripheral consolidation in patients with COVID-19. Septal thickening,&#xD;
      bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although&#xD;
      these findings are not specific to COVID-19, the severity of pulmonary involvement is&#xD;
      expected to be correlated with thorax CT findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the&#xD;
      severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the&#xD;
      initial thorax computed tomography severity score can predict mechanical ventilation&#xD;
      requirement and mortality in COVID-19 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Invasive respiratory support in patients with COVID-19</measure>
    <time_frame>120 days</time_frame>
    <description>Whether Thorax CT findings predict invasive mechanical ventilation requirement of covid-19 patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality in patients with COVID-19</measure>
    <time_frame>120 days</time_frame>
    <description>Whether Thorax CT findings predict mortality of covid-19 patients</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID-19 patients</arm_group_label>
    <description>Patient tested positive for COVID-19 who had a CT scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT-Scan</intervention_name>
    <description>Chest CT scan on admission to the intensive care unit</description>
    <arm_group_label>COVID-19 patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient admitted to the intensive care unit with COVID-19 pneumonia confirmed by RT-PCR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  COVID-19 confirmed by positive RT-PCR and/or antibody testing&#xD;
&#xD;
          -  CT scan at intensive care unit admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Loss of CT data&#xD;
&#xD;
          -  Chronic lung disease findings by CT that may lead to misinterpretation&#xD;
&#xD;
          -  RT-PCR results unavailable or negative&#xD;
&#xD;
          -  Terminal cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Işıl K Güldoğan</last_name>
    <phone>02324330810</phone>
    <email>isilkose66@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tepecik Training and Research Hospital</name>
      <address>
        <city>Izmir</city>
        <state>Izmir, Konak</state>
        <zip>35170</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Işıl Köse Güldoğan</last_name>
      <phone>+902324330810</phone>
      <email>isilkose66@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Kazim Rollas</last_name>
      <phone>+905532787535</phone>
      <email>kazim.rollas@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Işıl Köse Güldoğan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yeliz Pekçevik</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Naciye Sinem GEZER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kazım Rollas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Çiler Zincircioğlu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Uğur Uzun</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>İsa Sahar</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Taner Çalışkan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aykut Sarıtaş</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nimet Şenoğlu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tepecik Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Kazim Rollas</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </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/NCT04424849
org study id: 2020/5-4
nct id: NCT04424849
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The most common thorax Computed tomography (CT) findings are multifocal ground-glass
      opacities and peripheral consolidation in patients with COVID-19. Septal thickening,
      bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although
      these findings are not specific to COVID-19, the severity of pulmonary involvement is
      expected to be correlated with thorax CT findings.
Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the
      severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the
      initial thorax computed tomography severity score can predict mechanical ventilation
      requirement and mortality in COVID-19 patients.
observational model: Cohort
time perspective: Retrospective
measure: Invasive respiratory support in patients with COVID-19
time frame: 120 days
description: Whether Thorax CT findings predict invasive mechanical ventilation requirement of covid-19 patients
measure: Mortality in patients with COVID-19
time frame: 120 days
description: Whether Thorax CT findings predict mortality of covid-19 patients
arm group label: COVID-19 patients
description: Patient tested positive for COVID-19 who had a CT scan
intervention type: Diagnostic Test
intervention name: CT-Scan
description: Chest CT scan on admission to the intensive care unit
arm group label: COVID-19 patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Işıl K Güldoğan
phone: 02324330810
email: isilkose66@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Tepecik Training and Research Hospital
investigator full name: Kazim Rollas
investigator title: MD
mesh term: COVID-19
sharing ipd: No