Covid19SARS-CoV2-NBINCT04884061
Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection
An observational study of Covid19 and Bronchoscopy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Bronchoscopy, Narrow-band Imaging
- What is being tested?
- NBI images and/or videos
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2021to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe). Three groups of patients will be selected: 1) Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test ; 2) patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) ; 3) Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).
Who may be able to join
- Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe).
- Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test
- patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)
- Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).
Who cannot join
- Patients under legal protection
- Patients who refuses the use of his personal medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy
Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.
- Conditions
- Covid19, Bronchoscopy, Narrow-band Imaging
- Being tested
- NBI images and/or videos
- Keywords
- Covid19, bronchoscopy, Narrow-band imaging, bronchial vasculature, Acute vascular distress syndrome
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI images and/or videosOther
A library of NBI images and/or videos will be established from previously recorded bronchoscopies in 30 patients (10 with a SARS-CoV2 infection, 10 with a lower respiratory tract infection not related to SARS-CoV2, and 10 in patients with pulmonary nodule). NBI images and/or videos of the bronchial tree will then be analysed by three experimented interventional pulmonologists blinded to the patient ID. Each investigator will describe the vasculature pattern according to a prespecified grid: Normal mucosal vascularity / increased capillary density / presence of capillary loops / presence of dotted vessels / complex vascular networks of tortuous vessels or abrupt ending vessels / dilated longitudinal vessels. In case of discordance between the investigators, images will be reviewed to obtain a consensus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test Receives: Other: NBI images and/or videos | |
| Comparator | Patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) Receives: Other: NBI images and/or videos | |
| Comparator 2 | Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2). Receives: Other: NBI images and/or videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the vasculature pattern of the bronchial mucosa between the three patient groups
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start4 May 2021
- Primary completion12 Jan 2023
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884061
- Sponsor's protocol ID
- PI2021_843_0096
- Acronym
- SARS-CoV2-NBI
- Status last verified
- Jun 2026
- First submitted
- 7 May 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy
- ClinicalTrials.gov ID
- NCT04884061
- Acronym / sponsor ID
- SARS-CoV2-NBI / PI2021_843_0096
- Conditions
- Covid19, Bronchoscopy, Narrow-band Imaging
- Keywords
- Covid19, bronchoscopy, Narrow-band imaging, bronchial vasculature, Acute vascular distress syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 May 2021 (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.
Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: NBI images and/or videosPatients hospitalized with SARS-CoV2 infection proven by RT-PCR test |
| Comparator | – | Other: NBI images and/or videosPatients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) |
| Comparator 2 | – | Other: NBI images and/or videosPatients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe). Three groups of patients will be selected: 1) Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test ; 2) patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) ; 3) Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).
Key inclusion criteria (4 listed)
- Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe).
- Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test
- patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)
- Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).
Key exclusion criteria (2 listed)
- Patients under legal protection
- Patients who refuses the use of his personal medical data
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 |
|---|---|---|
| NBI images and/or videosA library of NBI images and/or videos will be established from previously recorded bronchoscopies in 30 patients (10 with a SARS-CoV2 infection, 10 with a lower respiratory tract infection not related to SARS-CoV2, and 10 in patients with pulmonary nodule). NBI images and/or videos of the bronchial tree will then be analysed by three experimented interventional pulmonologists blinded to the patient ID. Each investigator will describe the vasculature pattern according to a prespecified grid: Normal mucosal vascularity / increased capillary density / presence of capillary loops / presence of dotted vessels / complex vascular networks of tortuous vessels or abrupt ending vessels / dilated longitudinal vessels. In case of discordance between the investigators, images will be reviewed to obtain a consensus. | Other | Comparator, Comparator 2, Experimental |
Primary outcome
Variation of the vasculature pattern of the bronchial mucosa between the three patient groups
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Bronchoscopy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the vasculature pattern of the bronchial mucosa between the three patient groups (time frame: 2 months). 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 15 Jun 2026.