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NCT06423560 Clinical Trial

Pulmonary Fibrosis After Severe COVID-19 Pneumonia

COVID-19 Clinical Trial

— SPIFFERO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06423560
Other study ID # CET 145-2024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 16, 2024

Study information
Verified date May 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%. 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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date May 16, 2024
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Computed tomography
Follow-up computed tomography at 3-6 months and 12 months

Locations
Country Name City State
Italy IRCCS San Raffaele Milano Lombardia

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The magnitude of pulmonary involvement 12 months
Secondary results of respiratory function testing 12 months
Secondary echocardiographic parameters 12 months
Secondary persistence of symptoms 12 months
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