<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/NCT04403009</url>
  </required_header>
  <id_info>
    <org_study_id>YLS2020(112)</org_study_id>
    <nct_id>NCT04403009</nct_id>
  </id_info>
  <brief_title>The Clinical Difference Between the Nonfatal Patients and the Fatal Patients With Severe COVID-19</brief_title>
  <official_title>The Clinical Difference Between the Nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the Fatal Cases With Severe COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</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>
      To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019&#xD;
      (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to&#xD;
      compare the clinical information (laboratory and radiologic characteristics)of nonfatal&#xD;
      participants and fatal cases. The investigators wish figure out the clinical character of the&#xD;
      fatal participants. The result may help the physician to find the fatal patients with&#xD;
      COVID-19 more easily. The fatal patients with COVID-19 could be treated early.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 6, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lymphocyte cell</measure>
    <time_frame>2 month</time_frame>
    <description>the counting of Lymphocyte(counts/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>d-dimer</measure>
    <time_frame>2 month</time_frame>
    <description>d-dimer（mg/L）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PLT</measure>
    <time_frame>2 month</time_frame>
    <description>the counting of Platelets（(counts/L)）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRP</measure>
    <time_frame>2 month</time_frame>
    <description>the level of C-reactive protein (mg/uL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDH</measure>
    <time_frame>2 month</time_frame>
    <description>lactate dehydrogenase ( U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CK</measure>
    <time_frame>2 month</time_frame>
    <description>creatine kinase (U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PT</measure>
    <time_frame>2 month</time_frame>
    <description>prothrombin time(second)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ALT</measure>
    <time_frame>2 month</time_frame>
    <description>alanine aminotransferase(U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AST</measure>
    <time_frame>2 month</time_frame>
    <description>aspartate aminotransferase(U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell</measure>
    <time_frame>2 month</time_frame>
    <description>natural killer cell(counts/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCT</measure>
    <time_frame>2 month</time_frame>
    <description>procalcitonin（ng/ml）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6</measure>
    <time_frame>2 month</time_frame>
    <description>interleukin-6(mg/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases</measure>
    <time_frame>2 months</time_frame>
    <description>CT scan feature</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SPO2</measure>
    <time_frame>2 month</time_frame>
    <description>oxygen Saturation</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Coronavirus Disease 2019</condition>
  <condition>Character of the Severe Patients</condition>
  <arm_group>
    <arm_group_label>the nonsevere Coronavirus Disease 2019 Patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>the severe Coronavirus Disease 2019 Patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>no intervention</description>
    <arm_group_label>the nonsevere Coronavirus Disease 2019 Patients</arm_group_label>
    <arm_group_label>the severe Coronavirus Disease 2019 Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with Coronavirus Disease 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients with Coronavirus Disease 2019&#xD;
&#xD;
          -  Positive result on real-time reverse-transcriptase-polymerase-chain-reaction&#xD;
&#xD;
          -  Positive result on chest computed tomography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jianheng zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Afiliated hospital of Guangzhou medical university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guanzhou</city>
        <state>Guangdong</state>
        <zip>520120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hankou Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 4, 2023</last_update_submitted>
  <last_update_submitted_qc>March 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Zhang Jianheng</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is not decided</ipd_description>
  </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/NCT04403009
org study id: YLS2020(112)
nct id: NCT04403009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the difference of the difference between the nonfatal Coronavirus Disease 2019
      (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to
      compare the clinical information (laboratory and radiologic characteristics)of nonfatal
      participants and fatal cases. The investigators wish figure out the clinical character of the
      fatal participants. The result may help the physician to find the fatal patients with
      COVID-19 more easily. The fatal patients with COVID-19 could be treated early.
observational model: Cohort
time perspective: Cross-Sectional
measure: Lymphocyte cell
time frame: 2 month
description: the counting of Lymphocyte(counts/L)
measure: d-dimer
time frame: 2 month
description: d-dimer（mg/L）
measure: PLT
time frame: 2 month
description: the counting of Platelets（(counts/L)）
measure: CRP
time frame: 2 month
description: the level of C-reactive protein (mg/uL)
measure: LDH
time frame: 2 month
description: lactate dehydrogenase ( U/L)
measure: CK
time frame: 2 month
description: creatine kinase (U/L)
measure: PT
time frame: 2 month
description: prothrombin time(second)
measure: ALT
time frame: 2 month
description: alanine aminotransferase(U/L)
measure: AST
time frame: 2 month
description: aspartate aminotransferase(U/L)
measure: NK cell
time frame: 2 month
description: natural killer cell(counts/L)
measure: PCT
time frame: 2 month
description: procalcitonin（ng/ml）
measure: IL-6
time frame: 2 month
description: interleukin-6(mg/L)
measure: the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases
time frame: 2 months
description: CT scan feature
measure: SPO2
time frame: 2 month
description: oxygen Saturation
arm group label: the nonsevere Coronavirus Disease 2019 Patients
arm group label: the severe Coronavirus Disease 2019 Patients
intervention type: Other
intervention name: no intervention
description: no intervention
arm group label: the nonsevere Coronavirus Disease 2019 Patients
arm group label: the severe Coronavirus Disease 2019 Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
last name: jianheng zhang, MD
role: Principal Investigator
affiliation: First Afiliated hospital of Guangzhou medical university
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Zhang Jianheng
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Undecided
ipd description: It is not decided