<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/NCT04423315</url>
  </required_header>
  <id_info>
    <org_study_id>20200504443</org_study_id>
    <nct_id>NCT04423315</nct_id>
  </id_info>
  <brief_title>Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia</brief_title>
  <acronym>Covid-19</acronym>
  <official_title>Thrombosis Risk Assessment May Predict Clinical Presentation and Length of Hospital Stay in Covid-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Nisantasi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Nisantasi 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>
      Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly&#xD;
      progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due&#xD;
      to infection-associated inflammation and the resulting cytokine storm, are strongly&#xD;
      associated with high mortality rates. In this study, the association between thrombosis risk&#xD;
      and clinical presentation of Covid-19 is investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The severe acute respiratory distress syndrome related coronavirus-2 (SARS-CoV-2) and its&#xD;
      clinical presentation as Coronavirus disease 2019 (COVID-19) was first reported in Wuhan,&#xD;
      Hubei, China in December 2019. It has spread rapidly from its origin in Wuhan City to other&#xD;
      countries of the world over the last several months.&#xD;
&#xD;
      Although it mainly affects the respiratory system , multiple organ dysfunction and a&#xD;
      particularly progressive respiratory insufficiency along with a widespread coagulopathy&#xD;
      presumed to be due to infection-associated inflammation and the resulting cytokine storm, are&#xD;
      strongly associated with high mortality rates. SARS-CoV-2 infection may also lead to&#xD;
      thrombotic disease both in the venous and arterial circulation of patients apart from&#xD;
      respiratory system due to excessive inflammation, thrombocyte activation, endothelial&#xD;
      malfunction, and stasis.&#xD;
&#xD;
      Investigators have reported that both CHADS2 and CHA2DS2-VASc scores were related to&#xD;
      mortality in individuals that had stable coronary angina, acute coronary syndrome, Takotsubo&#xD;
      syndrome or sick sinus syndrome, apart from atrial fibrillation . In addition,&#xD;
      thrombocyte/lymphocyte (PLT/LYM) and neutrophil/lymphocyte (NEU/LYM) ratios on admission were&#xD;
      also related with thromboembolic complications in former studies which found them useful to&#xD;
      predict prognosis of acute pulmonary embolism, as being one of the thromboembolic&#xD;
      complications of Covid-19.&#xD;
&#xD;
      Investigators suggest that the parameters mentioned above should also be studied in terms of&#xD;
      thrombotic complications of Covid-19. Thus they aimed to find out potential associations&#xD;
      between markers of prothrombotic or inflammatory conditions and some clinical features of&#xD;
      Covid-19 pneumonia cases on admission and follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>length of hospital stay</measure>
    <time_frame>2 months</time_frame>
    <description>from admission to discharge expressed in days</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Thromboembolic Disease</condition>
  <arm_group>
    <arm_group_label>patients with covid-19 pneumonia</arm_group_label>
    <description>patients with covid-19 pneumonia above 18 years old who were diagnosed by pcr testing and computed tomography of thorax</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with COVID - 19 pneumonia diagnosed in the emergency, internal medicine and&#xD;
        cardiology outpatient clinics will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with COVID - 19 pneumonia between March 11 th , 2020 and April&#xD;
             25th, 2020 in the emergency, internal medicine and cardiology outpatient clinics.&#xD;
&#xD;
          -  patients diagnosed by pcr testing and computed tomography of the chest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients below 18 years of age&#xD;
&#xD;
          -  patients with an alternative aetiology of pneumonia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vital Hospital</name>
      <address>
        <city>Bahcelievler</city>
        <state>Istanbul</state>
        <zip>34230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Wang Q, Ma J, Jiang Z, Ming L. Prognostic value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in acute pulmonary embolism: a systematic review and meta-analysis. Int Angiol. 2018 Feb;37(1):4-11. doi: 10.23736/S0392-9590.17.03848-2. Epub 2017 May 24.</citation>
    <PMID>28541022</PMID>
  </reference>
  <reference>
    <citation>Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198. No abstract available.</citation>
    <PMID>32119647</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Nisantasi University</investigator_affiliation>
    <investigator_full_name>Murat Civan</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>covid-19 pneumonia</keyword>
  <keyword>thromboembolism risk</keyword>
  <keyword>length of hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD excluding names and personal identity numbers will be shared when the research is ready to be submitted for publication</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/NCT04423315
org study id: 20200504443
nct id: NCT04423315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly
      progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due
      to infection-associated inflammation and the resulting cytokine storm, are strongly
      associated with high mortality rates. In this study, the association between thrombosis risk
      and clinical presentation of Covid-19 is investigated.
The severe acute respiratory distress syndrome related coronavirus-2 (SARS-CoV-2) and its
      clinical presentation as Coronavirus disease 2019 (COVID-19) was first reported in Wuhan,
      Hubei, China in December 2019. It has spread rapidly from its origin in Wuhan City to other
      countries of the world over the last several months.

      Although it mainly affects the respiratory system , multiple organ dysfunction and a
      particularly progressive respiratory insufficiency along with a widespread coagulopathy
      presumed to be due to infection-associated inflammation and the resulting cytokine storm, are
      strongly associated with high mortality rates. SARS-CoV-2 infection may also lead to
      thrombotic disease both in the venous and arterial circulation of patients apart from
      respiratory system due to excessive inflammation, thrombocyte activation, endothelial
      malfunction, and stasis.

      Investigators have reported that both CHADS2 and CHA2DS2-VASc scores were related to
      mortality in individuals that had stable coronary angina, acute coronary syndrome, Takotsubo
      syndrome or sick sinus syndrome, apart from atrial fibrillation . In addition,
      thrombocyte/lymphocyte (PLT/LYM) and neutrophil/lymphocyte (NEU/LYM) ratios on admission were
      also related with thromboembolic complications in former studies which found them useful to
      predict prognosis of acute pulmonary embolism, as being one of the thromboembolic
      complications of Covid-19.

      Investigators suggest that the parameters mentioned above should also be studied in terms of
      thrombotic complications of Covid-19. Thus they aimed to find out potential associations
      between markers of prothrombotic or inflammatory conditions and some clinical features of
      Covid-19 pneumonia cases on admission and follow-up.
observational model: Cohort
time perspective: Retrospective
measure: length of hospital stay
time frame: 2 months
description: from admission to discharge expressed in days
arm group label: patients with covid-19 pneumonia
description: patients with covid-19 pneumonia above 18 years old who were diagnosed by pcr testing and computed tomography of thorax
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Wang Q, Ma J, Jiang Z, Ming L. Prognostic value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in acute pulmonary embolism: a systematic review and meta-analysis. Int Angiol. 2018 Feb;37(1):4-11. doi: 10.23736/S0392-9590.17.03848-2. Epub 2017 May 24.
PMID: 28541022
citation: Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198. No abstract available.
PMID: 32119647
responsible party type: Principal Investigator
investigator affiliation: Istanbul Nisantasi University
investigator full name: Murat Civan
investigator title: M.D.
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Coronavirus Infections
mesh term: Thrombosis
mesh term: Thromboembolism
sharing ipd: Undecided
ipd description: IPD excluding names and personal identity numbers will be shared when the research is ready to be submitted for publication