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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451889
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
COVID-19 Device: miniprobe Alveoflex Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: Confocal laser endomicroscopy diagnostic study

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
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
Other Name: Cellvizio system (Mauna Kea Technologies, Paris, France)




Primary Outcome Measures :
  1. Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants [ Time Frame: 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 :
  1. 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451889


Contacts
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Contact: Olesya Danilevskaya, MD, PhD +7(916)9819853 danless@mail.ru

Locations
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Russian Federation
Federal Research Clinical Center FMBA Russia Recruiting
Moscow, Russian Federation, 115682
Contact: Olesya V. Danilevskaya, MD    +7(916)9819853    danless@mail.ru   
Sponsors and Collaborators
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Investigators
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Principal Investigator: Olesya Danilevskaya, MD, PhD Federal Research Clinical Center FMBA Russia
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Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT04451889    
Other Study ID Numbers: COVID-pCLE
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes