Pulmonary Fibrosis After Severe COVID-19 Pneumonia

Completed

• Conditions: Pulmonary Fibrosis; COVID-19
• Interventions: Radiation: Computed tomography

• Registration Number: NCT06423560
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2022-03-01
• Status Verified: 2024-05
• Study Completion: 2024-05-16
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Residual disease > 20% of the total lung volume was considered pathological at follow-up CT	Computed tomography	-
Residual disease < 20% of the total lung volume was considered pathological at follow-up CT	Computed tomography	-

Primary Outcome Measures

Name	Time	Method
The magnitude of pulmonary involvement	12 months

Secondary Outcome Measures

Name	Time	Method
echocardiographic parameters	12 months
results of respiratory function testing	12 months
persistence of symptoms	12 months

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milano, Lombardia, Italy