Covid19Paesi-COV-19NCT04741178
PAtterns and Extension in COVID-19 Related Interstitial Pneumonia: CT Analysis
An observational study of Covid19, run by Morgagni Pierantoni Hospital at 1 site in Italy.
Trial summary
The hallmark of the L phenotype is the vasoplegia, as confirmed by the rapid change in density and distribution of CT findings from the supine to the prone position. The benefit of a prone position in awake, nonintubated, spontaneously breathing Covid-19 patients has been emerging as potential tool to improve… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Patients were considered eligible if were with a confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL, aged between 18 and 90 years old, able to maintain both the supine and prone position on the CT scan table. Patients who were pregnant, scarcely collaborative were excluded. CT analysis was conducted by two experienced thoracic radiologists and one pulmonologist. Extension of each CT finding and presence of vessel enlargement has been scored.
Who may be able to join
- Confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL
- Age between 18 and 90 years old
- Ability to maintain both the supine and prone position on the CT scan table.
Who cannot join
- Patients who were pregnant, scarcely collaborative
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Morgagni Pierantoni Hospital
Forlì, FC, 47121
Sara Piciucchi, MD, +390543 735863, piciucchi.sara@gmail.com
About this study
The hallmark of the L phenotype is the vasoplegia, as confirmed by the rapid change in density and distribution of CT findings from the supine to the prone position. The benefit of a prone position in awake, nonintubated, spontaneously breathing Covid-19 patients has been emerging as potential tool to improve oxygenation and to prevent the access to ICU.
No evidence of radiological modifications related to Aim of our study is to evaluate CT changes in terms of extension, distribution and prevalence of findings, in the supine compared with the prone position.
Read the detailed description
Patients were considered eligible if were with a confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL, aged between 18 and 90 years old, able to maintain both the supine and prone position on the CT scan table. Patients who were pregnant, scarcely collaborative were excluded.
Once adopted the supine position on the CT scan table, the patient received the oximeter. At the end of the supine scan, arterial oxygenation was recorded. Soon after the supine scan the patient adopted prone position with both arms extended anteriorly. CT scan was performed with a low dosage protocol, finally the second arterial oxygenation was recorded at the end of the prone scan. Patients who had oxygen requirement below 3 L/min temporarily suspended the supply; whilst those with an oxygen supply more than 3 L/min maintained it.
Three experienced radiologists analyzed CT images on a PACS workstation, in three stages. First to score the total severity score, secondly to analyze the supine scan and finally the prone CT images. The images were viewed in the lung window settings (width 1000-1500 HU; level 700 to -550 HU).
The TSS was calculated dividing each lung into three zones. The upper zone included parenchyma above the carina; the middle zone from carina and inferiori pulmonary vein and, finally the lower zone included the parenchyma below the inferior pulmonary vein. Each lung zone was further subdivided into anterior and posterior, so that the resulting zones were 12. Each zone was scored as follows: 0 with no changes; 1 with changes extent <25%; 2 with changes between 26 and 50%; 3, 51-75% and finally 4, >75%. To obtain the final score, the sum of each zone score was calculated, with a maximum value of 48.
After this first step, for each zone, the percentage of extension of patterns was calculated visually and recorded. Patterns included: pure ground glass; crazy paving; part-solid ground glass; perilobular pattern, and consolidation. This semiquantitative evaluation of this five patterns, was then evaluated for the prone scanning. The extension of the five patterns were averaged multiplying 1 for ground glass, 2 for crazy paving; 3 for part solid ground glass; 4 for perilobular pattern and 5 for consolidation. Each zone showed a final averaged score. Summarization of the anterior zones and posterior allows to calculate the anterior-posterior ratio both in supine and prone. Moreover, summarizing the scores in supine and prone, the prone-supine ratio has been calculated. A target vein, representing a "outside" vessel enlargement" has ben identified in dorsal segment of right upper lobe or in the posterobasal segment of right lower lobe, measured in supine and prone, and calculated prone-supine ratio.
In a final step, CT scan has been reviewed in consensus with pulmonologists in order to define qualitative pattern.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Covid-pneumonia | Patient with CT scan of pulmonary infiltrates suggestive of Covid pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT evidence of peculiar patterns in Covid-19 pneumonia
Identification of CT findings in order to define peculiar pattern of Covid-19 pneumonia
Measured: March 2020-January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start20 Mar 2020
- Primary completion2 Jan 2021
- Study completion31 Dec 2021 (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
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morgagni Pierantoni Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Piciucchi, Morgagni Pierantoni Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741178
- Sponsor's protocol ID
- Paesi-COV-19
- Acronym
- Paesi-COV-19
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAtterns and Extension in COVID-19 Related Interstitial Pneumonia: CT Analysis
- ClinicalTrials.gov ID
- NCT04741178
- Acronym / sponsor ID
- Paesi-COV-19 / Paesi-COV-19
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Morgagni Pierantoni HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 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.
The hallmark of the L phenotype is the vasoplegia, as confirmed by the rapid change in density and distribution of CT findings from the supine to the prone position. The benefit of a prone position in awake, nonintubated, spontaneously breathing Covid-19 patients has been emerging as potential tool to improve oxygenation and to prevent the access to ICU.
No evidence of radiological modifications related to Aim of our study is to evaluate CT changes in terms of extension, distribution and prevalence of findings, in the supine compared with the prone position.
Detailed description
Patients were considered eligible if were with a confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL, aged between 18 and 90 years old, able to maintain both the supine and prone position on the CT scan table. Patients who were pregnant, scarcely collaborative were excluded.
Once adopted the supine position on the CT scan table, the patient received the oximeter. At the end of the supine scan, arterial oxygenation was recorded. Soon after the supine scan the patient adopted prone position with both arms extended anteriorly. CT scan was performed with a low dosage protocol, finally the second arterial oxygenation was recorded at the end of the prone scan. Patients who had oxygen requirement below 3 L/min temporarily suspended the supply; whilst those with an oxygen supply more than 3 L/min maintained it.
Three experienced radiologists analyzed CT images on a PACS workstation, in three stages. First to score the total severity score, secondly to analyze the supine scan and finally the prone CT images. The images were viewed in the lung window settings (width 1000-1500 HU; level 700 to -550 HU).
The TSS was calculated dividing each lung into three zones. The upper zone included parenchyma above the carina; the middle zone from carina and inferiori pulmonary vein and, finally the lower zone included the parenchyma below the inferior pulmonary vein. Each lung zone was further subdivided into anterior and posterior, so that the resulting zones were 12. Each zone was scored as follows: 0 with no changes; 1 with changes extent <25%; 2 with changes between 26 and 50%; 3, 51-75% and finally 4, >75%. To obtain the final score, the sum of each zone score was calculated, with a maximum value of 48.
After this first step, for each zone, the percentage of extension of patterns was calculated visually and recorded. Patterns included: pure ground glass; crazy paving; part-solid ground glass; perilobular pattern, and consolidation. This semiquantitative evaluation of this five patterns, was then evaluated for the prone scanning. The extension of the five patterns were averaged multiplying 1 for ground glass, 2 for crazy paving; 3 for part solid ground glass; 4 for perilobular pattern and 5 for consolidation. Each zone showed a final averaged score. Summarization of the anterior zones and posterior allows to calculate the anterior-posterior ratio both in supine and prone. Moreover, summarizing the scores in supine and prone, the prone-supine ratio has been calculated. A target vein, representing a "outside" vessel enlargement" has ben identified in dorsal segment of right upper lobe or in the posterobasal segment of right lower lobe, measured in supine and prone, and calculated prone-supine ratio.
In a final step, CT scan has been reviewed in consensus with pulmonologists in order to define qualitative pattern.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Covid-pneumonia | – | –Patient with CT scan of pulmonary infiltrates suggestive of Covid pneumonia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were considered eligible if were with a confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL, aged between 18 and 90 years old, able to maintain both the supine and prone position on the CT scan table. Patients who were pregnant, scarcely collaborative were excluded. CT analysis was conducted by two experienced thoracic radiologists and one pulmonologist. Extension of each CT finding and presence of vessel enlargement has been scored.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL
- Age between 18 and 90 years old
- Ability to maintain both the supine and prone position on the CT scan table.
Key exclusion criteria (1 listed)
- Patients who were pregnant, scarcely collaborative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CT evidence of peculiar patterns in Covid-19 pneumonia
Time frame: March 2020-January 2021
Identification of CT findings in order to define peculiar pattern of Covid-19 pneumonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
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, run by Morgagni Pierantoni Hospital at 1 site in Italy.
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 3 inclusion and 1 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 10 Feb 2021. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT evidence of peculiar patterns in Covid-19 pneumonia (time frame: March 2020-January 2021). 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 10 Feb 2021.