<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/NCT04433754</url>
  </required_header>
  <id_info>
    <org_study_id>UsakU-Cevdet2</org_study_id>
    <nct_id>NCT04433754</nct_id>
  </id_info>
  <brief_title>The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection</brief_title>
  <official_title>Pancreatic Injury in Patients With COVID-19 Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uşak University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uşak 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>
      Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)&#xD;
      affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal&#xD;
      system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.&#xD;
&#xD;
      In this study, it was aimed retrospective analysis of clinical and laboratory data of&#xD;
      patients who developed pancreatic injury in the course of COVID 19 disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to compare presence of fever in patients with and without pancreatic injury</measure>
    <time_frame>3 month</time_frame>
    <description>To evaluate the frequency of presence of fever in patients with and without pancreatic injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>to compare presence of dyspnea in patients with and without pancreatic injury</measure>
    <time_frame>3 month</time_frame>
    <description>To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare cRP levels in patients with and without pancreatic injury</measure>
    <time_frame>3 month</time_frame>
    <description>CRP levels will be compared in patients with and without pancreatic injury</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To compare d-dimer levels in patients with and without pancreatic injury</measure>
    <time_frame>3 month</time_frame>
    <description>D-Dimer levels will be compared in patients with and without pancreatic injury</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>patients with pancreatic injury</arm_group_label>
    <description>patients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients without pancreatic injury</arm_group_label>
    <description>patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biochemical analysis</intervention_name>
    <description>cRP, d-dimer levels and lymphocyte counts will be compared</description>
    <arm_group_label>patients with pancreatic injury</arm_group_label>
    <arm_group_label>patients without pancreatic injury</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who develop amylase and lipase elevation during the course of COVID 19 will be&#xD;
        considered in the pancreatic injury group. Those who do not develop will be counted as the&#xD;
        control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with amylase and lipase levels measured during covid-19 disease with or&#xD;
             without pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pregnancy&#xD;
&#xD;
          -  Patients whose amylase and lipase levels were not measured during covid 19 disease&#xD;
&#xD;
          -  Patients with known solid organ malignacy&#xD;
&#xD;
          -  Patients with known hematologic malignacy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Usak University Training and Research Hospital</name>
      <address>
        <city>Usak</city>
        <zip>64200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uşak University</investigator_affiliation>
    <investigator_full_name>Cevdet Duran</investigator_full_name>
    <investigator_title>Professor, M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</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/NCT04433754
org study id: UsakU-Cevdet2
nct id: NCT04433754
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
      affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal
      system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.

      In this study, it was aimed retrospective analysis of clinical and laboratory data of
      patients who developed pancreatic injury in the course of COVID 19 disease.
observational model: Case-Control
time perspective: Retrospective
measure: to compare presence of fever in patients with and without pancreatic injury
time frame: 3 month
description: To evaluate the frequency of presence of fever in patients with and without pancreatic injury
measure: to compare presence of dyspnea in patients with and without pancreatic injury
time frame: 3 month
description: To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury
measure: To compare cRP levels in patients with and without pancreatic injury
time frame: 3 month
description: CRP levels will be compared in patients with and without pancreatic injury
measure: To compare d-dimer levels in patients with and without pancreatic injury
time frame: 3 month
description: D-Dimer levels will be compared in patients with and without pancreatic injury
arm group label: patients with pancreatic injury
description: patients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection
arm group label: patients without pancreatic injury
description: patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection
intervention type: Other
intervention name: biochemical analysis
description: cRP, d-dimer levels and lymphocyte counts will be compared
arm group label: patients with pancreatic injury
arm group label: patients without pancreatic injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Uşak University
investigator full name: Cevdet Duran
investigator title: Professor, M.D.
mesh term: Pancreatitis
sharing ipd: No