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

Study Overview
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Brief Summary
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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).

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

Conditions
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COVID-19

Intervention / Treatment
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* Device: miniprobe Alveoflex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Confocal laser endomicroscopy diagnostic study<br>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. | Device: miniprobe Alveoflex<br>* 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<br>* Other names: Cellvizio system (Mauna Kea Technologies, Paris, France);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to one year |