<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/NCT04420312</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-EP</org_study_id>
    <secondary_id>MR 4516150520</secondary_id>
    <nct_id>NCT04420312</nct_id>
  </id_info>
  <brief_title>Prevalence and Characteristics of Pulmonary Embolism on COVID-19 Patients Presenting Respiratory Symptoms</brief_title>
  <acronym>COVID-EP</acronym>
  <official_title>Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <brief_summary>
    <textblock>
      Multicentric case-control study that is aims at:&#xD;
&#xD;
        -  evaluating the prevalence of pulmonary embolism among a large population of consecutive&#xD;
           patients admitted for COVID-19 pneumonia into two large university hospitals in Paris,&#xD;
           France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges&#xD;
           Pompidou (HEGP)&#xD;
&#xD;
        -  and identifying the characteristics associated with pulmonary embolism by using a nested&#xD;
           case control study design within the patients who underwent either unenhanced computed&#xD;
           tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, China reported the first cluster of severe acute respiratory syndrome due&#xD;
      to a new coronavirus (SARS-CoV-2). The disease rapidly spread into a global pandemic of&#xD;
      public health emergency worldwide leading to more than 330.000 deaths (data from May 25th,&#xD;
      2020). We have, to date, no demonstration on the efficacy of any drug to cure or prevent&#xD;
      severe evolution of the disease (COVID-19). The primary target of SARS-CoV-2 is the lung with&#xD;
      frequent occurrence of acute respiratory distress syndrome (ARDS) justifying supportive care,&#xD;
      including invasive mechanical ventilation (IMV). The characteristics of ARDS in COVID-19&#xD;
      patients appeared atypical due to the dissociation between initial well-conserved lung&#xD;
      compliance and severe hypoxemia, attributed to pulmonary vasoregulation disruption and local&#xD;
      thrombogenesis. Strikingly high D-dimers levels, caused by both inflammation storm and&#xD;
      coagulation activation, have been early reported in COVID-19 patients and have been&#xD;
      associated with increased mortality. A single observational study suggests that&#xD;
      anticoagulation is associated with a decreased mortality in severe COVID-19 patients. These&#xD;
      reports have led to several therapeutic propositions in terms of anticoagulant therapy from&#xD;
      worldwide scientific societies (Khider et al JMV 2020). Publications recently reported&#xD;
      thrombotic complications in series of severe COVID-19 patients admitted in ICU, but the&#xD;
      frequency of pulmonary embolism (PE) in larger cohort of COVID-19 patients of any severity&#xD;
      remains uncertain.&#xD;
&#xD;
      This cohort enrolled patients in whom PE is proven by CTPA and compared them into two&#xD;
      subgroups of controls matched for age and sex in whom PE was either excluded or non&#xD;
      suspected:&#xD;
&#xD;
        1. COVID-19 patients with a negative CTPA and&#xD;
&#xD;
        2. COVID-19 patients in whom only an unhenced CT was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 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>Impact of PE on COVID-19 patients</measure>
    <time_frame>March 1st, 2020</time_frame>
    <description>Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical and radiological characteristics</measure>
    <time_frame>April 20th,2020</time_frame>
    <description>Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1024</enrollment>
  <condition>Pulmonary Embolism</condition>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Enrolled the Covid-19 patients with a negative CT Pulmonary Angiogram.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Enrolled the Covid-19 patients in whom only a CT was performed.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged over 18 years, hospitalized for respiratory pathology, associated with the&#xD;
        COVID-19; confirmed by either a RT-PCR test or a CT scan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients &gt;18 years,&#xD;
&#xD;
          -  admitted for acute COVID-19 pneumonia and have recieved a chest CT scan during&#xD;
             hospitalization,&#xD;
&#xD;
          -  COVID-19 diagnosis confirmed by a positive result of a RT-PCR,&#xD;
&#xD;
          -  CT findings of COVID-19 pneumonia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Respiratory distress syndrome explained by other cause&#xD;
&#xD;
          -  Patients who refuse to participate to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  <verification_date>June 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>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pulmonary embolism</keyword>
  <keyword>covid-19</keyword>
  <keyword>CT</keyword>
  <keyword>D-Dimers</keyword>
  <keyword>ARDS</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>Embolism</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/NCT04420312
org study id: COVID-EP
secondary id: MR 4516150520
nct id: NCT04420312
lead sponsor: 
Multicentric case-control study that is aims at:

        -  evaluating the prevalence of pulmonary embolism among a large population of consecutive
           patients admitted for COVID-19 pneumonia into two large university hospitals in Paris,
           France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges
           Pompidou (HEGP)

        -  and identifying the characteristics associated with pulmonary embolism by using a nested
           case control study design within the patients who underwent either unenhanced computed
           tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.
In December 2019, China reported the first cluster of severe acute respiratory syndrome due
      to a new coronavirus (SARS-CoV-2). The disease rapidly spread into a global pandemic of
      public health emergency worldwide leading to more than 330.000 deaths (data from May 25th,
      2020). We have, to date, no demonstration on the efficacy of any drug to cure or prevent
      severe evolution of the disease (COVID-19). The primary target of SARS-CoV-2 is the lung with
      frequent occurrence of acute respiratory distress syndrome (ARDS) justifying supportive care,
      including invasive mechanical ventilation (IMV). The characteristics of ARDS in COVID-19
      patients appeared atypical due to the dissociation between initial well-conserved lung
      compliance and severe hypoxemia, attributed to pulmonary vasoregulation disruption and local
      thrombogenesis. Strikingly high D-dimers levels, caused by both inflammation storm and
      coagulation activation, have been early reported in COVID-19 patients and have been
      associated with increased mortality. A single observational study suggests that
      anticoagulation is associated with a decreased mortality in severe COVID-19 patients. These
      reports have led to several therapeutic propositions in terms of anticoagulant therapy from
      worldwide scientific societies (Khider et al JMV 2020). Publications recently reported
      thrombotic complications in series of severe COVID-19 patients admitted in ICU, but the
      frequency of pulmonary embolism (PE) in larger cohort of COVID-19 patients of any severity
      remains uncertain.

      This cohort enrolled patients in whom PE is proven by CTPA and compared them into two
      subgroups of controls matched for age and sex in whom PE was either excluded or non
      suspected:

        1. COVID-19 patients with a negative CTPA and

        2. COVID-19 patients in whom only an unhenced CT was performed.
observational model: Case-Control
time perspective: Retrospective
measure: Impact of PE on COVID-19 patients
time frame: March 1st, 2020
description: Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms
measure: Clinical and radiological characteristics
time frame: April 20th,2020
description: Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.
arm group label: Group 1
description: Enrolled the Covid-19 patients with a negative CT Pulmonary Angiogram.
arm group label: Group 2
description: Enrolled the Covid-19 patients in whom only a CT was performed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013
citation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
PMID: 31986264
citation: Baden LR, Rubin EJ. Covid-19 - The Search for Effective Therapy. N Engl J Med. 2020 May 7;382(19):1851-1852. doi: 10.1056/NEJMe2005477. Epub 2020 Mar 18. No abstract available.
PMID: 32187463
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responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: Undecided