<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/NCT04405869</url>
  </required_header>
  <id_info>
    <org_study_id>7779</org_study_id>
    <nct_id>NCT04405869</nct_id>
  </id_info>
  <brief_title>Thromboembolic Events in Severe COVID-19 Patients</brief_title>
  <acronym>COVICLOT</acronym>
  <official_title>Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      The main objective of this study is to describe the incidence of thromboembolic events in a&#xD;
      population of patients hospitalized in intensive care units in France for severe COVID-19.&#xD;
      The secondary objective of this study is to describe the evolution of hemostasis parameters&#xD;
      during the first two weeks of intensive care hospitalization and to evaluate the influence of&#xD;
      different anticoagulation regimens on these parameters and on the incidence of thromboembolic&#xD;
      events&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 29, 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of incidence of thromboembolic events in patients with Sars-CoV-2</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pulmonary Thromboembolism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a confirmed infection with the Sars-CoV-2 virus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed infection with the Sars-CoV-2 virus (RT-PCR)&#xD;
&#xD;
          -  Hospitalization in Intensive Care Unit&#xD;
&#xD;
          -  Age over 18 years Old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to participate in data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Charles TACQUARD, MD</last_name>
    <phone>33 3 69 55 16 08</phone>
    <email>charlesambroise.tacquard@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saïd CHAYER, PhD, HDR</last_name>
    <phone>33 3 88 11 66 90</phone>
    <email>said.chayer@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles TACQUARD, MD</last_name>
      <phone>33 3 69 55 16 08</phone>
      <email>charlesambroise.tacquard@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Annick STEIB, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Claude ROCHE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lea RYFFEL, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle GOUIN-THIBAULT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandre MANSOUR, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandre GODON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre ALBALADEJO, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne GODIER, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephan MANKIKIAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxime NGUYEN SOENEN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bélaïd BOUHEMAD, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie SUSEN, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Delphine GARRIGUE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien POISSY, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric KIPNIS, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile AUBRON, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 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</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>D-Dimers</keyword>
  <keyword>Anticoagulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thromboembolism</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/NCT04405869
org study id: 7779
nct id: NCT04405869
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to describe the incidence of thromboembolic events in a
      population of patients hospitalized in intensive care units in France for severe COVID-19.
      The secondary objective of this study is to describe the evolution of hemostasis parameters
      during the first two weeks of intensive care hospitalization and to evaluate the influence of
      different anticoagulation regimens on these parameters and on the incidence of thromboembolic
      events
observational model: Cohort
time perspective: Other
measure: Analysis of incidence of thromboembolic events in patients with Sars-CoV-2
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Charles TACQUARD, MD
phone: 33 3 69 55 16 08
email: charlesambroise.tacquard@chru-strasbourg.fr
last name: Saïd CHAYER, PhD, HDR
phone: 33 3 88 11 66 90
email: said.chayer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
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country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pulmonary Embolism
mesh term: Thromboembolism