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Pulmonary Fibrosis After Severe COVID-19 Pneumonia

Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06423560
Acronym
SPIFFERO
Enrollment
61
Registered
2024-05-21
Start date
2020-03-01
Completion date
2024-05-16
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Pulmonary Fibrosis

Keywords

COVID-19, Pulmonary fibrosis, ARDS, Computed tomography, pulmonary function test

Brief 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%. 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.

Interventions

RADIATIONComputed tomography

Follow-up computed tomography at 3-6 months and 12 months

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age \< 18 * Absence of previously cited test.

Design outcomes

Primary

MeasureTime frame
The magnitude of pulmonary involvement12 months

Secondary

MeasureTime frame
results of respiratory function testing12 months
echocardiographic parameters12 months
persistence of symptoms12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026