<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/NCT04413435</url>
  </required_header>
  <id_info>
    <org_study_id>2020-245</org_study_id>
    <nct_id>NCT04413435</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics of Critically Ill Patients With COVID-19</brief_title>
  <official_title>Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nevsehir Public Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nevsehir Public Hospital</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>
      Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer&#xD;
      monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and&#xD;
      the ICU capacity of the health-care system. Hence, it may be need a new scoring system for&#xD;
      contagious critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer&#xD;
      monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and&#xD;
      the ICU capacity of the health-care system. Therefore, many patients with confirmed COVID-19&#xD;
      with RT-PCR and/or suspected COVID-19 were hospitalized in ICUs with a limited number of&#xD;
      beds. This ambiguity can result in both contamination risk to uninfected patients and&#xD;
      occupancy rate of the limited ICU beds. Hence, it may be need a new scoring system for&#xD;
      contagious critically ill patients. The aim of this study was to describe the epidemiological&#xD;
      and clinical features of 75 critically ill patients due to COVID-19 and to compare confirmed&#xD;
      COVID-19 cases with suspected COVID-19 cases in our critical care units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Actual">December 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Polymerase Chain Reaction (PCR) test</measure>
    <time_frame>5 days</time_frame>
    <description>To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A scoring system for patients to be admitted to the intensive care unit</measure>
    <time_frame>5 days</time_frame>
    <description>To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Critical Illness</condition>
  <condition>Characteristics Disease</condition>
  <arm_group>
    <arm_group_label>Confirmed COVID-19 cases</arm_group_label>
    <description>Patients with PCR test positive were considered as the confirmed COVID-19 cases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected COVID-19 cases</arm_group_label>
    <description>The suspected COVID-19 cases were defined as follows: those who were interpreted in favor of the suspected covid-19 on c-CT by radiologists in addition to the typical symptoms of the novel coronavirus disease such as cough, high fever (&gt;38,5 °C), or dyspnea, and those with a history of contact with another confirmed COVID-19 patient in addition to typical symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>File Scanning</intervention_name>
    <description>The patients' epidemiological, clinical, laboratory, and radiological characteristics and treatment and outcomes data will accessed from Hospital Data Management System (HDMS) of Konya Training and Research Hospital and Public Health Management System (PHMS) of Ministry of Health.</description>
    <arm_group_label>Confirmed COVID-19 cases</arm_group_label>
    <arm_group_label>Suspected COVID-19 cases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with confirmed COVID-19 and suspected COVID-19 patients who hospitalized in&#xD;
        ICUs allocated for patients with novel coronavirus disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with confirmed COVID-19 and suspected COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients &lt;18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients &gt;18 years old</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Konya Trainig and Research Hospital</name>
      <address>
        <city>Konya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nevsehir Public Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Akif Yazar</investigator_full_name>
    <investigator_title>Specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT04413435
org study id: 2020-245
nct id: NCT04413435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer
      monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and
      the ICU capacity of the health-care system. Hence, it may be need a new scoring system for
      contagious critically ill patients.
Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer
      monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and
      the ICU capacity of the health-care system. Therefore, many patients with confirmed COVID-19
      with RT-PCR and/or suspected COVID-19 were hospitalized in ICUs with a limited number of
      beds. This ambiguity can result in both contamination risk to uninfected patients and
      occupancy rate of the limited ICU beds. Hence, it may be need a new scoring system for
      contagious critically ill patients. The aim of this study was to describe the epidemiological
      and clinical features of 75 critically ill patients due to COVID-19 and to compare confirmed
      COVID-19 cases with suspected COVID-19 cases in our critical care units.
observational model: Other
time perspective: Retrospective
measure: Polymerase Chain Reaction (PCR) test
time frame: 5 days
description: To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.
measure: A scoring system for patients to be admitted to the intensive care unit
time frame: 5 days
description: To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.
arm group label: Confirmed COVID-19 cases
description: Patients with PCR test positive were considered as the confirmed COVID-19 cases.
arm group label: Suspected COVID-19 cases
description: The suspected COVID-19 cases were defined as follows: those who were interpreted in favor of the suspected covid-19 on c-CT by radiologists in addition to the typical symptoms of the novel coronavirus disease such as cough, high fever (>38,5 °C), or dyspnea, and those with a history of contact with another confirmed COVID-19 patient in addition to typical symptoms.
intervention type: Other
intervention name: File Scanning
description: The patients' epidemiological, clinical, laboratory, and radiological characteristics and treatment and outcomes data will accessed from Hospital Data Management System (HDMS) of Konya Training and Research Hospital and Public Health Management System (PHMS) of Ministry of Health.
arm group label: Confirmed COVID-19 cases
arm group label: Suspected COVID-19 cases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: patients >18 years old
minimum age: 18 Years
maximum age: N/A
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Nevsehir Public Hospital
investigator full name: Mehmet Akif Yazar
investigator title: Specialist
mesh term: Coronavirus Infections
mesh term: Critical Illness