<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/NCT04465656</url>
  </required_header>
  <id_info>
    <org_study_id>2020-05-01</org_study_id>
    <nct_id>NCT04465656</nct_id>
  </id_info>
  <brief_title>Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic</brief_title>
  <acronym>COVID-EP</acronym>
  <official_title>Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital St. Joseph, Marseille, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital St. Joseph, Marseille, France</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>
      The purpose of the study COVID-EP is to classify all the complications occurring after the&#xD;
      diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative&#xD;
      by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020).&#xD;
      The patients will be followed for 1 year in order to provide clinical and paraclinical data&#xD;
      not yet published in the literature. In order to secondarily confirm the COVID-19 status of&#xD;
      initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The&#xD;
      collected complications will then be compared between each of the 3 following groups:&#xD;
      [PCR-COVID 19-Neg &amp; Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg &amp; Sero-COVID 19-Pos] versus&#xD;
      [PCR-COVID 19-Pos].&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>% of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis.</measure>
    <time_frame>6 months after PE diagnosis</time_frame>
    <description>PE complications :&#xD;
Chronic interstitial pathology, or&#xD;
Recurrence of PE, or&#xD;
Pulmonary hypertension, or&#xD;
Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis.</measure>
    <time_frame>12 months after PE diagnosis</time_frame>
    <description>PE complications :&#xD;
Chronic interstitial pathology, or&#xD;
Recurrence of PE, or&#xD;
Pulmonary hypertension, or&#xD;
Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis).</measure>
    <time_frame>3, 6 and 12 months after PE diagnosis</time_frame>
    <description>PE complications :&#xD;
Chronic interstitial pathology, or&#xD;
Recurrence of PE, or&#xD;
Pulmonary hypertension, or&#xD;
Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis</measure>
    <time_frame>3 months after PE diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments</measure>
    <time_frame>12 months after PE diagnosis</time_frame>
    <description>Category of treatments:&#xD;
Heparin + AVK&#xD;
Heparin + DOAC&#xD;
PE complication :&#xD;
Chronic interstitial pathology, or&#xD;
Recurrence of PE, or&#xD;
Pulmonary hypertension, or&#xD;
Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments</measure>
    <time_frame>12 months after PE diagnosis</time_frame>
    <description>Category of treatments:&#xD;
Heparin + AVK&#xD;
Heparin + DOAC&#xD;
Bleeding complications: classification 1-2-3-5 according to BARC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments</measure>
    <time_frame>12 months after PE diagnosis</time_frame>
    <description>Category of treatments:&#xD;
Heparin + AVK&#xD;
Heparin + DOAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)</measure>
    <time_frame>12 months after PE diagnosis</time_frame>
    <description>Category of treatments:&#xD;
Heparin + AVK&#xD;
Heparin + DOAC</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>[PCR-COVID 19-Pos] group</arm_group_label>
    <description>Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[PCR-COVID 19-Neg] group</arm_group_label>
    <description>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[PCR-COVID 19-Neg &amp; Sero-COVID 19-Pos] group</arm_group_label>
    <description>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs&#xD;
Having been tested positive in a serological test for COVID-19 at M3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[PCR-COVID 19-Neg &amp; Sero-COVID 19-Neg] group</arm_group_label>
    <description>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs&#xD;
Having been tested negative in a serological test for COVID-19 at M3</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serology test for COVID-19</intervention_name>
    <description>In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts:&#xD;
ELISA test&#xD;
Rapid Diagnostic tests (only if ELISA test is positive)</description>
    <arm_group_label>[PCR-COVID 19-Neg] group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 18 years,&#xD;
&#xD;
          -  Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by&#xD;
             ambulatory care or hospitalized),&#xD;
&#xD;
          -  Having given free and informed written consent,&#xD;
&#xD;
          -  Being affiliated with or benefiting from a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject to a measure for the protection of justice.&#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_contact>
    <last_name>Cécile Bielmann</last_name>
    <phone>0033 (0)4 88 73 10 70</phone>
    <email>cbielmann@hopital-saint-joseph.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rahmia AHAMADA</last_name>
    <phone>0033 (0)4 91 80 71 12</phone>
    <email>rahamada@hopital-saint-joseph.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Saint Joseph Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roger Rosario, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT04465656
org study id: 2020-05-01
nct id: NCT04465656
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study COVID-EP is to classify all the complications occurring after the
      diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative
      by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020).
      The patients will be followed for 1 year in order to provide clinical and paraclinical data
      not yet published in the literature. In order to secondarily confirm the COVID-19 status of
      initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The
      collected complications will then be compared between each of the 3 following groups:
      [PCR-COVID 19-Neg & Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg & Sero-COVID 19-Pos] versus
      [PCR-COVID 19-Pos].
observational model: Cohort
time perspective: Retrospective
measure: % of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis.
time frame: 6 months after PE diagnosis
description: PE complications :
Chronic interstitial pathology, or
Recurrence of PE, or
Pulmonary hypertension, or
Death.
measure: % of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis.
time frame: 12 months after PE diagnosis
description: PE complications :
Chronic interstitial pathology, or
Recurrence of PE, or
Pulmonary hypertension, or
Death.
measure: % of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis).
time frame: 3, 6 and 12 months after PE diagnosis
description: PE complications :
Chronic interstitial pathology, or
Recurrence of PE, or
Pulmonary hypertension, or
Death.
measure: % of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis
time frame: 3 months after PE diagnosis
measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments
time frame: 12 months after PE diagnosis
description: Category of treatments:
Heparin + AVK
Heparin + DOAC
PE complication :
Chronic interstitial pathology, or
Recurrence of PE, or
Pulmonary hypertension, or
Death.
measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments
time frame: 12 months after PE diagnosis
description: Category of treatments:
Heparin + AVK
Heparin + DOAC
Bleeding complications: classification 1-2-3-5 according to BARC
measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments
time frame: 12 months after PE diagnosis
description: Category of treatments:
Heparin + AVK
Heparin + DOAC
measure: Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)
time frame: 12 months after PE diagnosis
description: Category of treatments:
Heparin + AVK
Heparin + DOAC
arm group label: [PCR-COVID 19-Pos] group
description: Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs
arm group label: [PCR-COVID 19-Neg] group
description: Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
arm group label: [PCR-COVID 19-Neg & Sero-COVID 19-Pos] group
description: Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
Having been tested positive in a serological test for COVID-19 at M3
arm group label: [PCR-COVID 19-Neg & Sero-COVID 19-Neg] group
description: Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
Having been tested negative in a serological test for COVID-19 at M3
intervention type: Diagnostic Test
intervention name: Serology test for COVID-19
description: In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts:
ELISA test
Rapid Diagnostic tests (only if ELISA test is positive)
arm group label: [PCR-COVID 19-Neg] group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Bielmann
phone: 0033 (0)4 88 73 10 70
email: cbielmann@hopital-saint-joseph.fr
last name: Rahmia AHAMADA
phone: 0033 (0)4 91 80 71 12
email: rahamada@hopital-saint-joseph.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: No