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

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Status: Unknown

Conditions: COVID-19

Treatments: Device: miniprobe Alveoflex

Study type: Interventional

Funder types: Other

Identifiers

NCT04451889

COVID-pCLE

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Confocal laser endomicroscopy diagnostic study

Experimental group

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.

Treatment:

Device: miniprobe Alveoflex