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Pulmonary Fibrosis After Severe COVID-19 Pneumonia (SPIFFERO)

S

San Donato Group (GSD)

Status

Completed

Conditions

COVID-19
Pulmonary Fibrosis

Treatments

Radiation: Computed tomography

Study type

Observational

Funder types

Other

Identifiers

NCT06423560
CET 145-2024

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

61 participants in 2 patient groups

Residual disease > 20% of the total lung volume was considered pathological at follow-up CT
Treatment:
Radiation: Computed tomography
Residual disease < 20% of the total lung volume was considered pathological at follow-up CT
Treatment:
Radiation: Computed tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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