Pulmonary Fibrosis After Severe COVID-19 Pneumonia

NCT ID: NCT06423560

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-05-16

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.

Conditions

Pulmonary Fibrosis; COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Residual disease > 20% of the total lung volume was considered pathological at follow-up CT

Computed tomography

Intervention Type: RADIATION

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

Residual disease < 20% of the total lung volume was considered pathological at follow-up CT

Computed tomography

Intervention Type: RADIATION

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

Interventions

Computed tomography

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

Intervention Type: RADIATION

Other Intervention Names

Pulmonary function test; Echocardiography

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Fragasso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriele Fragasso, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

IRCCS San Raffaele

Milan, Lombardy, Italy

Countries

Italy

Other Identifiers

CET 145-2024

Identifier Type: -

Identifier Source: org_study_id