## Protocol Section
### Identification Module
**NCT ID:** NCT06423560

**Acronym:** SPIFFERO

**Brief Title:** Pulmonary Fibrosis After Severe COVID-19 Pneumonia

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

#### Organization Study ID Info
**ID:** CET 145-2024
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2024-05-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS San Raffaele

#### Responsible Party

**Investigator Affiliation:** IRCCS San Raffaele

**Investigator Full Name:** Gabriele Fragasso

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Pulmonary Fibrosis

- COVID-19

**Keywords:**

- COVID-19

- Pulmonary fibrosis

- ARDS

- Computed tomography

- pulmonary function test

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 61

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Radiation: Computed tomography

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

#### Arm Group 2

**Intervention Names:**

- Radiation: Computed tomography

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

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

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

**Description:** Follow-up computed tomography at 3-6 months and 12 months

**Name:** Computed tomography

**Other Names:**

- Pulmonary function test

- Echocardiography

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Measure:** The magnitude of pulmonary involvement

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** results of respiratory function testing

**Time Frame:** 12 months

**Measure:** echocardiographic parameters

**Time Frame:** 12 months

**Measure:** persistence of symptoms

**Time Frame:** 12 months

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Milano

**Country:** Italy

**Facility:** IRCCS San Raffaele

**State:** Lombardia

**Zip:** 20132

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS San Raffaele

**Name:** Gabriele Fragasso, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017563

- Term: Lung Diseases, Interstitial

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

- ID: M14512

- Name: Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Pulmonary Fibrosis

- ID: M13904

- Name: Pneumonia

- Relevance: HIGH

- As Found: Pneumonia

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19813

- Name: Lung Diseases, Interstitial

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000011014

- Term: Pneumonia

- ID: D000011658

- Term: Pulmonary Fibrosis

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-31
