<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/NCT04479137</url>
  </required_header>
  <id_info>
    <org_study_id>KSSEAH--PPC</org_study_id>
    <nct_id>NCT04479137</nct_id>
  </id_info>
  <brief_title>Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul</brief_title>
  <official_title>Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman 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>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It&#xD;
      is known that mortality based on COVID-19 is higher in old population. Therefore the aim of&#xD;
      this study to analyze the experience of 7 governmental hospitals in terms of patient&#xD;
      characteristics, possible risk factors of mortality based on COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to&#xD;
      many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It&#xD;
      is known that mortality based on COVID-19 is higher in old population. Although several&#xD;
      factors defined to be effective on this 'age depending factors' regional differences should&#xD;
      be assessed deeply to clarify both the etiology and epidemiology. Therefore the aim of this&#xD;
      study to analyze the experience of 7 governmental hospitals in terms of patient&#xD;
      characteristics, possible risk factors of mortality based on COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality based on COVID-19</measure>
    <time_frame>3 months</time_frame>
    <description>mortality based on COVID-19 within the patients aged between 18-50 will be evaluated</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Covid-19</condition>
  <condition>Risk Factor, Mortality</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PCR for COVID-19</intervention_name>
    <description>Novel Coronavirus 2019 DNA will be analyzed by PCR in nasopharyngeal swab</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were between 18-50 years of age and were died caused by COVID-19 will be&#xD;
        evaluated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  accepted to participate&#xD;
&#xD;
          -  patients who were proven to have COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  declined to participate&#xD;
&#xD;
          -  patients whose age under 18 or more than 50 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ramazan Guven</investigator_full_name>
    <investigator_title>Professor</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/NCT04479137
org study id: KSSEAH--PPC
nct id: NCT04479137
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It
      is known that mortality based on COVID-19 is higher in old population. Therefore the aim of
      this study to analyze the experience of 7 governmental hospitals in terms of patient
      characteristics, possible risk factors of mortality based on COVID-19.
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It
      is known that mortality based on COVID-19 is higher in old population. Although several
      factors defined to be effective on this 'age depending factors' regional differences should
      be assessed deeply to clarify both the etiology and epidemiology. Therefore the aim of this
      study to analyze the experience of 7 governmental hospitals in terms of patient
      characteristics, possible risk factors of mortality based on COVID-19.
observational model: Cohort
time perspective: Retrospective
measure: mortality based on COVID-19
time frame: 3 months
description: mortality based on COVID-19 within the patients aged between 18-50 will be evaluated
intervention type: Diagnostic Test
intervention name: PCR for COVID-19
description: Novel Coronavirus 2019 DNA will be analyzed by PCR in nasopharyngeal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Ramazan Guven
investigator title: Professor
mesh term: COVID-19
sharing ipd: No