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

Not Applicable

• Conditions: COVID-19
• Interventions: Device: miniprobe Alveoflex

• Registration Number: NCT04451889
• Lead Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-06-30
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24
• Study Start: 2020-08-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Confocal laser endomicroscopy diagnostic study	miniprobe Alveoflex	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.

Primary Outcome Measures

Name	Time	Method
Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants	up to one year	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

Name	Time	Method
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	up to one year	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.

Trial Locations

Locations (1)

Federal Research Clinical Center FMBA Russia; 🇷🇺 Moscow, Russian Federation