<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/NCT04451889</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-pCLE</org_study_id>
    <nct_id>NCT04451889</nct_id>
  </id_info>
  <brief_title>Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients</brief_title>
  <official_title>Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal Research Clinical Center of Federal Medical &amp; Biological Agency, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal Research Clinical Center of Federal Medical &amp; Biological Agency, Russia</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 study is devoted to the comparative analysis of the data received in patients with&#xD;
      COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of&#xD;
      distal airways and two reference methods: high resolution computed tomography and morphology&#xD;
      (in some patients).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">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>Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants</measure>
    <time_frame>up to one year</time_frame>
    <description>pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Correspondence of pCLE Images to High Resolution Computer Tomography and Morphologic Data as a Measure of Specificity and Sensitivity of the Method</measure>
    <time_frame>up to one year</time_frame>
    <description>pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Confocal laser endomicroscopy diagnostic study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1: COVID-19 patients. Cohort 2: patients with lung diseases unrelated to COVID-19.&#xD;
All the patients will be examined using confocal laser endomicroscopy during bronchoscopy with a special Alveoflex miniprobe during the hospitalisation period. Records will be done and analysed prospectively with the included software for the endomicroscopic system.&#xD;
Using Alveoflex is a minimally invasive intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>miniprobe Alveoflex</intervention_name>
    <description>Alveoflex uses 488nm laser, generating real time moving images with an optical area of 600μm at a video frame rate of 12 images per second and a focus depth of 50μm</description>
    <arm_group_label>Confocal laser endomicroscopy diagnostic study</arm_group_label>
    <other_name>Cellvizio system (Mauna Kea Technologies, Paris, France)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient Informed Consent;&#xD;
&#xD;
          -  the diagnosis of COVID-19 or one of the following lung diseases: chronic obstructive&#xD;
             pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic&#xD;
             interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary&#xD;
             eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis;&#xD;
             alveolar proteinosis, other rare lung disease&#xD;
&#xD;
          -  high resolution computed tomography scans performed not later than one month before&#xD;
             pCLE (for non-COVID-19);&#xD;
&#xD;
          -  planned or performed histology (for non-COVID-19)&#xD;
&#xD;
          -  Severe respiratory failure,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or breast feeding,&#xD;
&#xD;
          -  lung bleeding,&#xD;
&#xD;
          -  any acute or chronic disease that may be a contraindication to bronchoscopy,&#xD;
&#xD;
          -  any diseases of hematopoietic system,&#xD;
&#xD;
          -  taking part in other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olesya Danilevskaya, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Research Clinical Center FMBA Russia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olesya Danilevskaya, MD, PhD</last_name>
    <phone>+7(916)9819853</phone>
    <email>danless@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal Research Clinical Center FMBA Russia</name>
      <address>
        <city>Moscow</city>
        <zip>115682</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olesya V. Danilevskaya, MD</last_name>
      <phone>+7(916)9819853</phone>
      <email>danless@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no current plan to share individual participant data (IPD).</ipd_description>
  </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/NCT04451889
org study id: COVID-pCLE
nct id: NCT04451889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is devoted to the comparative analysis of the data received in patients with
      COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of
      distal airways and two reference methods: high resolution computed tomography and morphology
      (in some patients).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants
time frame: up to one year
description: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.
measure: Number of Participants With the Correspondence of pCLE Images to High Resolution Computer Tomography and Morphologic Data as a Measure of Specificity and Sensitivity of the Method
time frame: up to one year
description: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.
arm group label: Confocal laser endomicroscopy diagnostic study
arm group type: Experimental
description: Cohort 1: COVID-19 patients. Cohort 2: patients with lung diseases unrelated to COVID-19.
All the patients will be examined using confocal laser endomicroscopy during bronchoscopy with a special Alveoflex miniprobe during the hospitalisation period. Records will be done and analysed prospectively with the included software for the endomicroscopic system.
Using Alveoflex is a minimally invasive intervention.
intervention type: Device
intervention name: miniprobe Alveoflex
description: Alveoflex uses 488nm laser, generating real time moving images with an optical area of 600μm at a video frame rate of 12 images per second and a focus depth of 50μm
arm group label: Confocal laser endomicroscopy diagnostic study
other name: Cellvizio system (Mauna Kea Technologies, Paris, France)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Olesya Danilevskaya, MD, PhD
role: Principal Investigator
affiliation: Federal Research Clinical Center FMBA Russia
last name: Olesya Danilevskaya, MD, PhD
phone: +7(916)9819853
email: danless@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: There is no current plan to share individual participant data (IPD).