<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/NCT04507230</url>
  </required_header>
  <id_info>
    <org_study_id>17300413</org_study_id>
    <nct_id>NCT04507230</nct_id>
  </id_info>
  <brief_title>COVID-19 Associated Coagulopathy in Egypt</brief_title>
  <official_title>Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and&#xD;
      is associated with increased mortality and admission to critical care. Most commonly observed&#xD;
      coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is&#xD;
      characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive&#xD;
      hospitalization reported to have developed disseminated intravascular coagulation (DIC)&#xD;
      compared to 0.6% of survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      studying the detailed coagulation screen and second line coagulation parameters including&#xD;
      both thrombophilia screen and other acute phase coagulation factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Coagulation screen</measure>
    <time_frame>1 month</time_frame>
    <description>Full coagulation screen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thrombophilia screen</measure>
    <time_frame>1 month</time_frame>
    <description>Full thrombophilia screen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VWF, FVIII</measure>
    <time_frame>1 month</time_frame>
    <description>VWFAg, FVIII</description>
  </primary_outcome>
  <enrollment type="Actual">106</enrollment>
  <condition>Coagulopathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt.&#xD;
&#xD;
        Age and sex matched controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with COVID 19 positive by RT- PCR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Azza Abdelaal</investigator_full_name>
    <investigator_title>lecturer of clinical pathology</investigator_title>
  </responsible_party>
  <keyword>hypercoagulable</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT04507230
org study id: 17300413
nct id: NCT04507230
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and
      is associated with increased mortality and admission to critical care. Most commonly observed
      coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is
      characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive
      hospitalization reported to have developed disseminated intravascular coagulation (DIC)
      compared to 0.6% of survivors.
studying the detailed coagulation screen and second line coagulation parameters including
      both thrombophilia screen and other acute phase coagulation factors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Coagulation screen
time frame: 1 month
description: Full coagulation screen
measure: Thrombophilia screen
time frame: 1 month
description: Full thrombophilia screen
measure: VWF, FVIII
time frame: 1 month
description: VWFAg, FVIII
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Azza Abdelaal
investigator title: lecturer of clinical pathology
mesh term: COVID-19
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders