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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Morgagni Pierantoni Hospital

    Forlì, FC, 47121

    Sara Piciucchi, MD, +390543 735863, piciucchi.sara@gmail.com

    Recruiting

Other trials in Italy

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 groups in NCT04741178
Study groupRoleWhat they receive
Patient with Covid-pneumoniaPatient 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.

  1. 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.

  1. First posted5 Feb 2021
  2. Study start20 Mar 2020
  3. Primary completion2 Jan 2021
  4. Study completion31 Dec 2021 (estimated)

Resources

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)
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

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.

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