<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/NCT04408378</url>
  </required_header>
  <id_info>
    <org_study_id>69</org_study_id>
    <nct_id>NCT04408378</nct_id>
  </id_info>
  <brief_title>Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients</brief_title>
  <official_title>Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaziosmanpasa Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gaziosmanpasa Research and Education 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>
      Morbidity, mortality and progress depends on systemic inflammation especially in ARDS&#xD;
      patients. Previous studies claims that the proportion of mean platellet volume to platellet&#xD;
      which can simply be determined with simple blood tests that are performed at admission, might&#xD;
      predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical&#xD;
      outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for&#xD;
      detecting the progress of Covid-19 pneumonia or not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous&#xD;
      of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS.&#xD;
      Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of&#xD;
      Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a&#xD;
      tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by&#xD;
      March-May 2020, the patients over 18 years old who were in either intensive care or ward&#xD;
      scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been&#xD;
      collected from the written resources and electronic data retrospectively.&#xD;
&#xD;
      the patients who are diagnosed with Covid*19 pneumonia will be divided into two groups. The&#xD;
      ones in the ward will be considered as mild clinical course, and the ones in the intensive&#xD;
      care unit will be considered as severe clinical course. there will be an additional non Covid&#xD;
      individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT&#xD;
      will be calculated using admission hemogrames of these groups, and the significance of the&#xD;
      statistical differences on determining the prognosis of the disease will be discussed.&#xD;
&#xD;
      Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., &amp; Lang, A.-G. (2009). Statistical&#xD;
      power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior&#xD;
      Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using&#xD;
      ANOVA test between at least two independent groups. In order to provide enoughsample&#xD;
      magnitude power, which is 0.8, it was calculated that each group should have 52 patients&#xD;
      which makes at total of 156.&#xD;
&#xD;
      The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric&#xD;
      ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal&#xD;
      distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA&#xD;
      test. Categoric data will be compared by Pearson ki square test and the p values less than&#xD;
      0.05 will be considered as significant.&#xD;
&#xD;
      we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 5, 2020</start_date>
  <completion_date type="Anticipated">August 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 20, 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>estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio</measure>
    <time_frame>March-May 2020</time_frame>
    <description>İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>mild pneumonia</arm_group_label>
    <description>The patients who has followed in the ward</description>
  </arm_group>
  <arm_group>
    <arm_group_label>severe pneumonia</arm_group_label>
    <description>The patiens who has followed in the intensive care unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>patients who has not covid 19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation of covid 19 pneumonia</intervention_name>
    <description>We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>mild pneumonia</arm_group_label>
    <arm_group_label>severe pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between&#xD;
        march and may 2020 in the ICU or ward.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia&#xD;
             between march and may 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old patients&#xD;
&#xD;
          -  Patients with heamolytic diaseses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gaziosmanpaşa TREH</name>
      <address>
        <city>Istanbul</city>
        <state>Gaziosmanpaşa</state>
        <zip>34255</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>aygen türkmen, MD.prof.</last_name>
      <phone>+902129453000</phone>
      <phone_ext>1436</phone_ext>
      <email>aygenturkmen@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>zuhal çavuş, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kim CH, Kim SJ, Lee MJ, Kwon YE, Kim YL, Park KS, Ryu HJ, Park JT, Han SH, Yoo TH, Kang SW, Oh HJ. An increase in mean platelet volume from baseline is associated with mortality in patients with severe sepsis or septic shock. PLoS One. 2015 Mar 5;10(3):e0119437. doi: 10.1371/journal.pone.0119437. eCollection 2015.</citation>
    <PMID>25742300</PMID>
  </reference>
  <reference>
    <citation>Fei Y, Zhang H, Zhang C. The application of lymphocyte*platelet and mean platelet volume/platelet ratio in influenza A infection in children. J Clin Lab Anal. 2019 Nov;33(9):e22995. doi: 10.1002/jcla.22995. Epub 2019 Aug 16.</citation>
    <PMID>31420904</PMID>
  </reference>
  <reference>
    <citation>Korniluk A, Koper-Lenkiewicz OM, Kaminska J, Kemona H, Dymicka-Piekarska V. Mean Platelet Volume (MPV): New Perspectives for an Old Marker in the Course and Prognosis of Inflammatory Conditions. Mediators Inflamm. 2019 Apr 17;2019:9213074. doi: 10.1155/2019/9213074. eCollection 2019.</citation>
    <PMID>31148950</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>covid-19, MPV/PLT, pneumonia</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04408378
org study id: 69
nct id: NCT04408378
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Morbidity, mortality and progress depends on systemic inflammation especially in ARDS
      patients. Previous studies claims that the proportion of mean platellet volume to platellet
      which can simply be determined with simple blood tests that are performed at admission, might
      predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical
      outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for
      detecting the progress of Covid-19 pneumonia or not.
Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous
      of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS.
      Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of
      Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a
      tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by
      March-May 2020, the patients over 18 years old who were in either intensive care or ward
      scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been
      collected from the written resources and electronic data retrospectively.

      the patients who are diagnosed with Covid*19 pneumonia will be divided into two groups. The
      ones in the ward will be considered as mild clinical course, and the ones in the intensive
      care unit will be considered as severe clinical course. there will be an additional non Covid
      individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT
      will be calculated using admission hemogrames of these groups, and the significance of the
      statistical differences on determining the prognosis of the disease will be discussed.

      Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical
      power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior
      Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using
      ANOVA test between at least two independent groups. In order to provide enoughsample
      magnitude power, which is 0.8, it was calculated that each group should have 52 patients
      which makes at total of 156.

      The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric
      ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal
      distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA
      test. Categoric data will be compared by Pearson ki square test and the p values less than
      0.05 will be considered as significant.

      we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.
observational model: Case-Control
time perspective: Retrospective
measure: estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio
time frame: March-May 2020
description: İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.
arm group label: mild pneumonia
description: The patients who has followed in the ward
arm group label: severe pneumonia
description: The patiens who has followed in the intensive care unit
arm group label: control group
description: patients who has not covid 19 pneumonia
intervention type: Other
intervention name: observation of covid 19 pneumonia
description: We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio
arm group label: control group
arm group label: mild pneumonia
arm group label: severe pneumonia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
citation: Kim CH, Kim SJ, Lee MJ, Kwon YE, Kim YL, Park KS, Ryu HJ, Park JT, Han SH, Yoo TH, Kang SW, Oh HJ. An increase in mean platelet volume from baseline is associated with mortality in patients with severe sepsis or septic shock. PLoS One. 2015 Mar 5;10(3):e0119437. doi: 10.1371/journal.pone.0119437. eCollection 2015.
PMID: 25742300
citation: Fei Y, Zhang H, Zhang C. The application of lymphocyte*platelet and mean platelet volume/platelet ratio in influenza A infection in children. J Clin Lab Anal. 2019 Nov;33(9):e22995. doi: 10.1002/jcla.22995. Epub 2019 Aug 16.
PMID: 31420904
citation: Korniluk A, Koper-Lenkiewicz OM, Kaminska J, Kemona H, Dymicka-Piekarska V. Mean Platelet Volume (MPV): New Perspectives for an Old Marker in the Course and Prognosis of Inflammatory Conditions. Mediators Inflamm. 2019 Apr 17;2019:9213074. doi: 10.1155/2019/9213074. eCollection 2019.
PMID: 31148950
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Coronavirus Infections
sharing ipd: Undecided