COVID-19 Clinical Trial
— SPIFFEROOfficial title:
Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)
| 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 |
| Verified date | May 2024 |
| Source | IRCCS San Raffaele |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS San Raffaele | Milano | Lombardia |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
Italy,
| 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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