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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451889
• Other study ID #: COVID-pCLE
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: Olesya Danilevskaya, MD, PhD
• Phone: +7(916)9819853
• Email: danless[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Intervention

Device:
• miniprobe Alveoflex
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

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center FMBA Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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