<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/NCT04483752</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01322-37</org_study_id>
    <nct_id>NCT04483752</nct_id>
  </id_info>
  <brief_title>Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images</brief_title>
  <acronym>PREDISCAN</acronym>
  <official_title>Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Chirurgical Marie Lannelongue</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Chirurgical Marie Lannelongue</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 differences observed between SARSCoV-2 pneumonia and other epidemic viral&#xD;
      pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the&#xD;
      clinical severity of the disease, particularly in young patients without co-morbidities, and&#xD;
      the observation of radiological images related to significant parenchymal aggression in a&#xD;
      large number of patients.&#xD;
&#xD;
      The lesions in the acute phase correspond essentially to bilateral ground glass opacity more&#xD;
      or less associated with condensations which would be markers of more severe infections.&#xD;
&#xD;
      The major scope of the lesions in the acute phase raises the question of whether or not the&#xD;
      scanning anomalies are completely resolved over time, and the possible impact on lung&#xD;
      function. This risk of sequelae is very important to study given the large number of patients&#xD;
      affected by SARSCoV-2, especially since these are often young patients who appear to be&#xD;
      &quot;healthy&quot;.&#xD;
&#xD;
      In the current context of the CoV-2 SARS pandemic, the improved quality and availability of&#xD;
      diagnostic scanners provides a wealth of information on the semiology and progression of lung&#xD;
      disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with&#xD;
      SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of&#xD;
      Radiology has recommended the performance of a CT scan without injection in thin sections in&#xD;
      case of suspicion or for confirmation of the diagnosis in patients presenting initial or&#xD;
      secondary clinical signs of severity and justifying hospital management due to the initial&#xD;
      lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT&#xD;
      scan and its specificity in epidemic periods.&#xD;
&#xD;
      The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the&#xD;
      predictive character of the chest CT scan performed at the patient's discharge on the&#xD;
      existence of radiological sequelae at 3 months but also at 1 year in order not to&#xD;
      misunderstand the constitution of late fibrosis after partial resolution of the CT images.&#xD;
      The investigatos will study the correlation between possible radiological abnormalities and&#xD;
      the clinical presentation (patient symptoms and lung function). The rigorous follow-up of&#xD;
      these patients will allow us to set up, if necessary, early treatment of the detected&#xD;
      abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the&#xD;
      place of an anti-fibrosis treatment in case of fibrosis,...).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">December 24, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 24, 2021</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>description of the different types of lesions</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>CoV2 SARS Pneumonia</condition>
  <arm_group>
    <arm_group_label>Patients hospitalised for SARS CoV-2 infection.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHEST CT SCAN</intervention_name>
    <description>Chest CTscan at 3 and 12 months</description>
    <arm_group_label>Patients hospitalised for SARS CoV-2 infection.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical&#xD;
             SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed&#xD;
             when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital&#xD;
             discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.&#xD;
&#xD;
          -  Patient ≥ 18 years old&#xD;
&#xD;
          -  Patient who has given free, informed and written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient ≤ 18 years old&#xD;
&#xD;
          -  CT Contraindication&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#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>CAROLINE CARAMELLA, MD</last_name>
    <phone>01.40.94.85.71</phone>
    <email>a.caramella@hml.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Marie Lannelongue</name>
      <address>
        <city>Le Plessis-Robinson</city>
        <zip>92350</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CAROLINE CARAMELLA, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marie De Torcy</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy (IGR)</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Corinne Institut Gustave Roussy (IGR), MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS CoV2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Fibrosis</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/NCT04483752
org study id: 2020-A01322-37
nct id: NCT04483752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral
      pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the
      clinical severity of the disease, particularly in young patients without co-morbidities, and
      the observation of radiological images related to significant parenchymal aggression in a
      large number of patients.

      The lesions in the acute phase correspond essentially to bilateral ground glass opacity more
      or less associated with condensations which would be markers of more severe infections.

      The major scope of the lesions in the acute phase raises the question of whether or not the
      scanning anomalies are completely resolved over time, and the possible impact on lung
      function. This risk of sequelae is very important to study given the large number of patients
      affected by SARSCoV-2, especially since these are often young patients who appear to be
      "healthy".

      In the current context of the CoV-2 SARS pandemic, the improved quality and availability of
      diagnostic scanners provides a wealth of information on the semiology and progression of lung
      disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with
      SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of
      Radiology has recommended the performance of a CT scan without injection in thin sections in
      case of suspicion or for confirmation of the diagnosis in patients presenting initial or
      secondary clinical signs of severity and justifying hospital management due to the initial
      lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT
      scan and its specificity in epidemic periods.

      The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the
      predictive character of the chest CT scan performed at the patient's discharge on the
      existence of radiological sequelae at 3 months but also at 1 year in order not to
      misunderstand the constitution of late fibrosis after partial resolution of the CT images.
      The investigatos will study the correlation between possible radiological abnormalities and
      the clinical presentation (patient symptoms and lung function). The rigorous follow-up of
      these patients will allow us to set up, if necessary, early treatment of the detected
      abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the
      place of an anti-fibrosis treatment in case of fibrosis,...).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: description of the different types of lesions
time frame: 3 months
measure: quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae
time frame: 3 months
arm group label: Patients hospitalised for SARS CoV-2 infection.
arm group type: Other
intervention type: Other
intervention name: CHEST CT SCAN
description: Chest CTscan at 3 and 12 months
arm group label: Patients hospitalised for SARS CoV-2 infection.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CAROLINE CARAMELLA, MD
phone: 01.40.94.85.71
email: a.caramella@hml.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Fibrosis