COVID-19NCT04451889
Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
A study testing miniprobe Alveoflex in people with COVID-19, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- miniprobe Alveoflex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal Research Clinical Center FMBA Russia
Moscow, 115682
Olesya V. Danilevskaya, MD, +7(916)9819853, danless@mail.ru
About this study
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).
- Conditions
- COVID-19
- Being tested
- miniprobe Alveoflex
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniprobe AlveoflexDevice
Also called Cellvizio system (Mauna Kea Technologies, Paris, France)
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
| Study group | Role | What they receive |
|---|---|---|
| Confocal laser endomicroscopy diagnostic study | Experimental | 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. Receives: Device: miniprobe Alveoflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one year
Secondary outcomes (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
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.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olesya Danilevskaya, MD, PhD, Principal investigator, Federal Research Clinical Center FMBA Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451889
- Sponsor's protocol ID
- COVID-pCLE
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04451889
- Acronym / sponsor ID
- COVID-pCLE
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal laser endomicroscopy diagnostic study | Experimental | Device: miniprobe AlveoflexCohort 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miniprobe AlveoflexAlso: Cellvizio system (Mauna Kea Technologies, Paris, France)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 | Device | Confocal laser endomicroscopy diagnostic study |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olesya Danilevskaya, MD, PhD principal investigator
Federal Research Clinical Center FMBA Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miniprobe Alveoflex in people with COVID-19, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olesya Danilevskaya, MD, PhD (+7(916)9819853, danless@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.