<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/NCT04479540</url>
  </required_header>
  <id_info>
    <org_study_id>2020_0058</org_study_id>
    <nct_id>NCT04479540</nct_id>
  </id_info>
  <brief_title>Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease</brief_title>
  <acronym>COVIDEP</acronym>
  <official_title>Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Ambroise Paré Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>Yes</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 current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is&#xD;
      complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy.&#xD;
      Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.&#xD;
&#xD;
      The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths&#xD;
      have been linked to pulmonary embolism (PE).&#xD;
&#xD;
      Recognition of PE is important because there is specific treatment to limit its own&#xD;
      mortality. The identification of biological parameters of hemostasis predictive of&#xD;
      thromboembolic disease is crucial in these patients.&#xD;
&#xD;
      To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a&#xD;
      systematic thoracic angiography scanner in the patients having no contra-indication for its&#xD;
      realization, as well as during hospitalization in patients deteriorating without any other&#xD;
      obvious cause.&#xD;
&#xD;
      The thromboembolic events and disturbances of the coagulation system described in patients&#xD;
      with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase&#xD;
      in the activation of coagulation contributing to the occurrence of thrombosis and especially&#xD;
      from PE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is&#xD;
      complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy.&#xD;
      Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.&#xD;
&#xD;
      On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are&#xD;
      hospitalized in intensive care and 4,503 patients died.&#xD;
&#xD;
      The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths&#xD;
      have been linked to pulmonary embolism (PE). Very little data is available in the medical&#xD;
      literature regarding PE during this infection.&#xD;
&#xD;
      Recognition of PE is important because there is specific treatment to limit its own&#xD;
      mortality. The identification of biological parameters of hemostasis predictive of&#xD;
      thromboembolic disease is crucial in these patients who are difficult to mobilize.&#xD;
&#xD;
      The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE&#xD;
      make it necessary to evaluate the frequency of it in the patients having to be hospitalized&#xD;
      by the practice of a systematic thoracic angiography scanner in the patients having no&#xD;
      contra-indication for its realization, as well as during hospitalization in patients&#xD;
      deteriorating without any other obvious cause.&#xD;
&#xD;
      The thromboembolic events and disturbances of the coagulation system described in patients&#xD;
      with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase&#xD;
      in the activation of coagulation contributing to the occurrence of thrombosis and especially&#xD;
      from PE.&#xD;
&#xD;
      The main objective of this work is therefore to determine the incidence of the occurrence of&#xD;
      PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic&#xD;
      angiography scanner in all hospitalized patients.&#xD;
&#xD;
      The secondary objective is to study the coagulation and fibrinolysis profile in these&#xD;
      patients and to assess endothelial activation in order to better understand the&#xD;
      physio-pathological mechanism behind PE and to determine if one of the parameters studied&#xD;
      could be an indicator of PE risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">March 5, 2022</completion_date>
  <primary_completion_date type="Actual">February 26, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients with pulmonary embolism</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prothrombin level measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activated partial thromboplastin time measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrinogen measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimers measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein C measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willebrand antigen measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble tissue factor measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble thrombomodulin measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>E-selectin measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombin-antithrombin complex measurement</measure>
    <time_frame>up to Day 12</time_frame>
    <description>Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of clot formation curve</measure>
    <time_frame>Day 1</time_frame>
    <description>Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of thrombin generation</measure>
    <time_frame>Day 1</time_frame>
    <description>Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of fibrinolysis</measure>
    <time_frame>Day 1</time_frame>
    <description>Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 30</time_frame>
    <description>Determine patient mortality</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>Hospitalized SARS Cov-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized patients diagnosed with SARS Cov-2 infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Angiography scanner</intervention_name>
    <description>systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)</description>
    <arm_group_label>Hospitalized SARS Cov-2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years&#xD;
&#xD;
          -  Any patient who consults in the emergency room, COVID+ with hospitalization criteria&#xD;
             (dyspnea or desaturation ≤ 95% or chest pain or hemoptysis), including those who have&#xD;
             already performed a CT angiogram upon arrival at the hospital.&#xD;
&#xD;
          -  Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical&#xD;
             signs associated with suggestive radiological criteria&#xD;
&#xD;
               -  Fever&#xD;
&#xD;
               -  Cough&#xD;
&#xD;
               -  Myalgia&#xD;
&#xD;
               -  Asthenia&#xD;
&#xD;
               -  Loss of taste/ Anosmia&#xD;
&#xD;
          -  signed informed consent before any study procedure&#xD;
&#xD;
          -  patients affiliated to an appropriate health insurance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy in progress&#xD;
&#xD;
          -  Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection&#xD;
             or whose symptoms are not suggestive&#xD;
&#xD;
          -  &lt; 18 years&#xD;
&#xD;
          -  Be deprived of liberty or under guardianship&#xD;
&#xD;
          -  Patient with contra-indication to thoracic angiography scanner:&#xD;
&#xD;
               -  State of shock&#xD;
&#xD;
               -  Creatinine clearance &lt; 30 mL/mn in Chronic Kidney Disease (CKD)&#xD;
&#xD;
               -  history of anaphylactic shock or angioedema with iodinated contrast media&#xD;
&#xD;
               -  uncontrolled cardiac decompensation&#xD;
&#xD;
          -  Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):&#xD;
&#xD;
               -  History of immediate major or delayed skin reaction to the injection of a&#xD;
                  contrast medium&#xD;
&#xD;
               -  Hypersensitivity to the active substance or to any of the excipients&#xD;
&#xD;
               -  overt thyrotoxicosis&#xD;
&#xD;
        Patients with renal insufficiency and / or patients with allergy to iodinated contrast&#xD;
        products may be included if they can perform a scintigraphy (the pulmonary scintigraphy&#xD;
        being the alternative diagnostic to the CT angiography for renal insufficiency and / or&#xD;
        allergy to iodinated contrast products).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colas TCHERAKIAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foch HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS COV-2</keyword>
  <keyword>pulmonary embolism</keyword>
  <keyword>acute respiratory distress syndrome</keyword>
  <keyword>coagulation disorders</keyword>
  <keyword>venous thromboembolic disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Viral</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</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/NCT04479540
org study id: 2020_0058
nct id: NCT04479540
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is
      complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy.
      Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

      The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths
      have been linked to pulmonary embolism (PE).

      Recognition of PE is important because there is specific treatment to limit its own
      mortality. The identification of biological parameters of hemostasis predictive of
      thromboembolic disease is crucial in these patients.

      To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a
      systematic thoracic angiography scanner in the patients having no contra-indication for its
      realization, as well as during hospitalization in patients deteriorating without any other
      obvious cause.

      The thromboembolic events and disturbances of the coagulation system described in patients
      with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase
      in the activation of coagulation contributing to the occurrence of thrombosis and especially
      from PE.
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is
      complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy.
      Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

      On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are
      hospitalized in intensive care and 4,503 patients died.

      The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths
      have been linked to pulmonary embolism (PE). Very little data is available in the medical
      literature regarding PE during this infection.

      Recognition of PE is important because there is specific treatment to limit its own
      mortality. The identification of biological parameters of hemostasis predictive of
      thromboembolic disease is crucial in these patients who are difficult to mobilize.

      The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE
      make it necessary to evaluate the frequency of it in the patients having to be hospitalized
      by the practice of a systematic thoracic angiography scanner in the patients having no
      contra-indication for its realization, as well as during hospitalization in patients
      deteriorating without any other obvious cause.

      The thromboembolic events and disturbances of the coagulation system described in patients
      with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase
      in the activation of coagulation contributing to the occurrence of thrombosis and especially
      from PE.

      The main objective of this work is therefore to determine the incidence of the occurrence of
      PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic
      angiography scanner in all hospitalized patients.

      The secondary objective is to study the coagulation and fibrinolysis profile in these
      patients and to assess endothelial activation in order to better understand the
      physio-pathological mechanism behind PE and to determine if one of the parameters studied
      could be an indicator of PE risk.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rate of patients with pulmonary embolism
time frame: up to Day 12
description: Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
measure: Prothrombin level measurement
time frame: up to Day 12
description: Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: activated partial thromboplastin time measurement
time frame: up to Day 12
description: Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Fibrinogen measurement
time frame: up to Day 12
description: Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: D-dimers measurement
time frame: up to Day 12
description: Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Protein C measurement
time frame: up to Day 12
description: Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Willebrand antigen measurement
time frame: up to Day 12
description: Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Soluble tissue factor measurement
time frame: up to Day 12
description: Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Soluble thrombomodulin measurement
time frame: up to Day 12
description: Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: E-selectin measurement
time frame: up to Day 12
description: Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Thrombin-antithrombin complex measurement
time frame: up to Day 12
description: Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
measure: Assessment of clot formation curve
time frame: Day 1
description: Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
measure: Assessment of thrombin generation
time frame: Day 1
description: Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
measure: Assessment of fibrinolysis
time frame: Day 1
description: Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
measure: Mortality
time frame: Day 30
description: Determine patient mortality
arm group label: Hospitalized SARS Cov-2
arm group type: Experimental
description: Hospitalized patients diagnosed with SARS Cov-2 infection
intervention type: Radiation
intervention name: Angiography scanner
description: systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)
arm group label: Hospitalized SARS Cov-2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colas TCHERAKIAN, MD
role: Principal Investigator
affiliation: Foch HOSPITAL
facility: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia, Viral
mesh term: Lung Diseases
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: No