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Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
miniprobe Alveoflex
Sponsored by
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient Informed Consent;
  • the diagnosis of COVID-19 or one of the following lung diseases: chronic obstructive pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease
  • high resolution computed tomography scans performed not later than one month before pCLE (for non-COVID-19);
  • planned or performed histology (for non-COVID-19)
  • Severe respiratory failure,

Exclusion Criteria:

  • pregnancy or breast feeding,
  • lung bleeding,
  • any acute or chronic disease that may be a contraindication to bronchoscopy,
  • any diseases of hematopoietic system,
  • taking part in other clinical trials

Sites / Locations

  • Federal Research Clinical Center FMBA RussiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Confocal laser endomicroscopy diagnostic study

Arm 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.

Outcomes

Primary Outcome Measures

Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants
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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
June 29, 2020
Last Updated
July 22, 2020
Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT04451889
Brief Title
Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
Official Title
Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Confocal laser endomicroscopy diagnostic study
Arm Type
Experimental
Arm 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(s)
miniprobe Alveoflex
Other Intervention Name(s)
Cellvizio system (Mauna Kea Technologies, Paris, France)
Intervention 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
Primary Outcome Measure Information:
Title
Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants
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.
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
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
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.
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient Informed Consent; the diagnosis of COVID-19 or one of the following lung diseases: chronic obstructive pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease high resolution computed tomography scans performed not later than one month before pCLE (for non-COVID-19); planned or performed histology (for non-COVID-19) Severe respiratory failure, Exclusion Criteria: pregnancy or breast feeding, lung bleeding, any acute or chronic disease that may be a contraindication to bronchoscopy, any diseases of hematopoietic system, taking part in other clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olesya Danilevskaya, MD, PhD
Phone
+7(916)9819853
Email
danless@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olesya Danilevskaya, MD, PhD
Organizational Affiliation
Federal Research Clinical Center FMBA Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Research Clinical Center FMBA Russia
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olesya V. Danilevskaya, MD
Phone
+7(916)9819853
Email
danless@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data (IPD).

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Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients

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