Pulmonary FibrosisSPIFFERONCT06423560
Pulmonary Fibrosis After Severe COVID-19 Pneumonia
An observational study of Pulmonary Fibrosis and COVID-19, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Patients discharged after hospitalization for COVID-19 pneumonia were retrospectively selected by radiologically established criteria that at admission presented at chest computed tomography (CT) (i) normal lung parenchyma <50% of total lung volume; and/or (ii) area of lung consolidation > 10%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19
- What is being tested?
- Computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 16 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up
Who may be able to join
- Age ≥ 18
- Hospitalization for severe COVID-19 pneumonia
- Computed tomography during index hospitalization that showed: (i) normale lung parenchyma < 50% of total lung volume and/or (ii) parenchymal consolidation > 10%
- Cardiological and pneumological visit, echocardiography and pulmonary function test at 3 and 12 months from hospital discharge
- Computed tomography by 12 months from hospital discharge
Who cannot join
- Age < 18
- Absence of previously cited test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)
Patients discharged after hospitalization for COVID-19 pneumonia were retrospectively selected by radiologically established criteria that at admission presented at chest computed tomography (CT) (i) normal lung parenchyma <50% of total lung volume; and/or (ii) area of lung consolidation > 10%. All At discharge and after 9 months, all subjects underwent cardiological evaluation, echocardiogram, pulmonary function tests (PFT) both atby 3 and by 12 months after discharge. Chest CT was performed by 12 months after discharge and chest CT. Specifically, the magnitude of pulmonary involvement between baseline and follow-up was considered the primary endpoint of this study. Secondary endpoints of the study were results of respiratory function testing, echocardiographic parametersparameters, and persistence of symptoms.
- Conditions
- Pulmonary Fibrosis, COVID-19
- Being tested
- Computed tomography
- Keywords
- COVID-19, Pulmonary fibrosis, ARDS, Computed tomography, pulmonary function test
- Medical subject headings
- Pulmonary Fibrosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyRadiation
Also called Pulmonary function test, Echocardiography
Follow-up computed tomography at 3-6 months and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Residual disease > 20% of the total lung volume was considered pathological at follow-up CT | Not described Receives: Radiation: Computed tomography | |
| Residual disease < 20% of the total lung volume was considered pathological at follow-up CT | Not described Receives: Radiation: Computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude of pulmonary involvement
Measured: 12 months
Secondary outcomes (3)
results of respiratory function testing
Measured: 12 months
echocardiographic parameters
Measured: 12 months
persistence of symptoms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Mar 2020
- Primary completion1 Mar 2022
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Fragasso, IRCCS San Raffaele
- Investigators
- Gabriele Fragasso, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423560
- Sponsor's protocol ID
- CET 145-2024
- Acronym
- SPIFFERO
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT06423560
- Acronym / sponsor ID
- SPIFFERO / CET 145-2024
- Conditions
- Pulmonary Fibrosis, COVID-19
- Keywords
- COVID-19, Pulmonary fibrosis, ARDS, Computed tomography, pulmonary function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 21 May 2024 (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.
Patients discharged after hospitalization for COVID-19 pneumonia were retrospectively selected by radiologically established criteria that at admission presented at chest computed tomography (CT) (i) normal lung parenchyma <50% of total lung volume; and/or (ii) area of lung consolidation > 10%. All At discharge and after 9 months, all subjects underwent cardiological evaluation, echocardiogram, pulmonary function tests (PFT) both atby 3 and by 12 months after discharge. Chest CT was performed by 12 months after discharge and chest CT. Specifically, the magnitude of pulmonary involvement between baseline and follow-up was considered the primary endpoint of this study. Secondary endpoints of the study were results of respiratory function testing, echocardiographic parametersparameters, and persistence of symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residual disease > 20% of the total lung volume was considered pathological at follow-up CT | – | Radiation: Computed tomography |
| Residual disease < 20% of the total lung volume was considered pathological at follow-up CT | – | Radiation: Computed tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up
Key inclusion criteria (5 listed)
- Age ≥ 18
- Hospitalization for severe COVID-19 pneumonia
- Computed tomography during index hospitalization that showed: (i) normale lung parenchyma < 50% of total lung volume and/or (ii) parenchymal consolidation > 10%
- Cardiological and pneumological visit, echocardiography and pulmonary function test at 3 and 12 months from hospital discharge
- Computed tomography by 12 months from hospital discharge
Key exclusion criteria (2 listed)
- Age < 18
- Absence of previously cited test.
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 |
|---|---|---|
| Computed tomographyAlso: Pulmonary function test, EchocardiographyFollow-up computed tomography at 3-6 months and 12 months | Radiation | Residual disease < 20% of the total lung volume was considered pathological at follow-up CT, Residual disease > 20% of the total lung volume was considered pathological at follow-up CT |
Primary outcome
The magnitude of pulmonary involvement
Time frame: 12 months
3 secondary outcomes
results of respiratory function testing
Time frame: 12 months
echocardiographic parameters
Time frame: 12 months
persistence of symptoms
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Gabriele Fragasso, MD principal investigator
IRCCS San Raffaele
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 Pulmonary Fibrosis and COVID-19, run by IRCCS San Raffaele 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 5 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: finished, as of the sponsor's last update on 21 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The magnitude of pulmonary involvement (time frame: 12 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 21 May 2024.