<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/NCT04422613</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0181</org_study_id>
    <nct_id>NCT04422613</nct_id>
  </id_info>
  <brief_title>Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia</brief_title>
  <acronym>PULCO-19</acronym>
  <official_title>Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of&#xD;
      international Committee on taxonomy of viruses, is an emerging virus from the family of&#xD;
      coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral&#xD;
      pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which&#xD;
      conditions the prognosis of the disease.&#xD;
&#xD;
      Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day&#xD;
      as a result of possible hyperinflammatory response, the respiratory impairment of COVID is&#xD;
      unique and many questions remain unanswered concerning its evolution once the acute phase has&#xD;
      passed. Knowledge of the evolution of pulmonary involvement, particularly in patients&#xD;
      requiring hospitalization, can help reduce the morbidity linked to the persistent&#xD;
      abnormalities identified by establishing early therapeutic management. It can also provide a&#xD;
      better understanding of the mechanisms of pulmonary involvement in the acute phase. Current&#xD;
      data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain&#xD;
      distant from this infection at all levels of the respiratory system: gas exchange, perfusion,&#xD;
      ventilatory mechanics, and interstitial lung disease.&#xD;
&#xD;
      The main objective is to characterize persistent gas exchange anomalies 4 months after&#xD;
      documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring&#xD;
      hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Alteration of the DLCO</measure>
    <time_frame>4 month</time_frame>
    <description>Alteration of the DLCO test defined by a corrected DLCO value &lt;70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanism of the alteration of gas exchanges</measure>
    <time_frame>4 month</time_frame>
    <description>The mechanism of the alteration of gas exchanges will be specified by the analysis of the values obtained during the diffusing CO / NO test, at 4 month after COVID- 19 pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement on lung volumes</measure>
    <time_frame>4 month</time_frame>
    <description>The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during the measurement of lung volumes in respiratory function tests at 4 month after COVID- 19 pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanism of the alteration of gas exchanges by chest scan</measure>
    <time_frame>4 month</time_frame>
    <description>The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during chest CT-scan at 4 month after COVID- 19 pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanism of the alteration of gas exchanges by scintigraphy</measure>
    <time_frame>4 month</time_frame>
    <description>The mechanism of the alteration of gas exchanges identified will be specified by the analysis of the other values obtained during pulmonary scintigraphy, at 4 month after COVID- 19 pneumonia :</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory symptom</measure>
    <time_frame>4 month</time_frame>
    <description>the existence of respiratory symptoms, defined by dyspnea, cough, sputum, haemoptysis, chest pain, sign of right ventricular failure, sleep disorders or a 6-minute walk test value &lt;80% of theoretical, at 4 month after COVID- 19 pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchial or ventilatory anomalies</measure>
    <time_frame>4 month</time_frame>
    <description>the existence of persistent bronchial or ventilatory anomalies at 4 months, defined on current respiratory function tests (plethysmography, forced oscillometry test, diaphragmatic explorations, measurement of exhaled NO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistent respiratory anomalies</measure>
    <time_frame>12 month</time_frame>
    <description>Persistent respiratory anomalies at 4 months will be evaluated at 12 months of the acute episode by an appropriate paraclinical assessment : mechanism of the alteration of gas exchanges, Respiratory symptom and bronchial or ventilatory anomalies will be evaluated</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>characterization of pulmonary damage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pulmonary anomalies 4 months after documented COVID-19 pneumonia</intervention_name>
    <description>Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,</description>
    <arm_group_label>characterization of pulmonary damage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with COVID-19 pneumonia&#xD;
&#xD;
          -  Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial,&#xD;
             tracheal aspiration or LBA)&#xD;
&#xD;
          -  Having required hospitalization in the pulmonology service, intensive care in&#xD;
             pneumology or resuscitation service at the Toulouse University Hospital&#xD;
&#xD;
          -  Saturation &lt;94% in ambient air at diagnosis&#xD;
&#xD;
          -  Patient having a chest CT-scan proving pneumonia during his hospitalization&#xD;
&#xD;
          -  Patient ≥ 18 years old&#xD;
&#xD;
          -  Patient who has given written consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized for pneumonia not documented by a chest CT-scan&#xD;
&#xD;
          -  Patient with negative COVID PCR&#xD;
&#xD;
          -  Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac&#xD;
             pathology which can lead in itself to an alteration of gas exchanges&#xD;
&#xD;
          -  Patient under curators / guardianship&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Absence of consent for participation in the study&#xD;
&#xD;
          -  Medical condition that does not allow for pulmonary function test&#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>Elise Noël-Savina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Respiratory Function Tests</keyword>
  <keyword>Pulmonary Gas Exchange : Respiratory Tract Diseases</keyword>
  <keyword>Pulmonary Embolism</keyword>
  <keyword>Respiratory Distress Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Viral</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/NCT04422613
org study id: RC31/20/0181
nct id: NCT04422613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of
      international Committee on taxonomy of viruses, is an emerging virus from the family of
      coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral
      pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which
      conditions the prognosis of the disease.

      Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day
      as a result of possible hyperinflammatory response, the respiratory impairment of COVID is
      unique and many questions remain unanswered concerning its evolution once the acute phase has
      passed. Knowledge of the evolution of pulmonary involvement, particularly in patients
      requiring hospitalization, can help reduce the morbidity linked to the persistent
      abnormalities identified by establishing early therapeutic management. It can also provide a
      better understanding of the mechanisms of pulmonary involvement in the acute phase. Current
      data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain
      distant from this infection at all levels of the respiratory system: gas exchange, perfusion,
      ventilatory mechanics, and interstitial lung disease.

      The main objective is to characterize persistent gas exchange anomalies 4 months after
      documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring
      hospitalization.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Alteration of the DLCO
time frame: 4 month
description: Alteration of the DLCO test defined by a corrected DLCO value <70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2)
measure: Mechanism of the alteration of gas exchanges
time frame: 4 month
description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the values obtained during the diffusing CO / NO test, at 4 month after COVID- 19 pneumonia
measure: Measurement on lung volumes
time frame: 4 month
description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during the measurement of lung volumes in respiratory function tests at 4 month after COVID- 19 pneumonia
measure: mechanism of the alteration of gas exchanges by chest scan
time frame: 4 month
description: The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during chest CT-scan at 4 month after COVID- 19 pneumonia
measure: mechanism of the alteration of gas exchanges by scintigraphy
time frame: 4 month
description: The mechanism of the alteration of gas exchanges identified will be specified by the analysis of the other values obtained during pulmonary scintigraphy, at 4 month after COVID- 19 pneumonia :
measure: Respiratory symptom
time frame: 4 month
description: the existence of respiratory symptoms, defined by dyspnea, cough, sputum, haemoptysis, chest pain, sign of right ventricular failure, sleep disorders or a 6-minute walk test value <80% of theoretical, at 4 month after COVID- 19 pneumonia
measure: Bronchial or ventilatory anomalies
time frame: 4 month
description: the existence of persistent bronchial or ventilatory anomalies at 4 months, defined on current respiratory function tests (plethysmography, forced oscillometry test, diaphragmatic explorations, measurement of exhaled NO)
measure: Persistent respiratory anomalies
time frame: 12 month
description: Persistent respiratory anomalies at 4 months will be evaluated at 12 months of the acute episode by an appropriate paraclinical assessment : mechanism of the alteration of gas exchanges, Respiratory symptom and bronchial or ventilatory anomalies will be evaluated
arm group label: characterization of pulmonary damage
arm group type: Experimental
description: This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia
intervention type: Diagnostic Test
intervention name: pulmonary anomalies 4 months after documented COVID-19 pneumonia
description: Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
arm group label: characterization of pulmonary damage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elise Noël-Savina, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Viral
sharing ipd: No