Pulmonary Fibrosis After Severe COVID-19 Pneumonia (SPIFFERO)

May 16, 2024 updated by: Gabriele Fragasso, IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Residual disease > 20% of the total lung volume was considered pathological at follow-up CT
Radiation: Computed tomography
Follow-up computed tomography at 3-6 months and 12 months
Other Names:
  • Pulmonary function test
  • Echocardiography
Residual disease < 20% of the total lung volume was considered pathological at follow-up CT
Radiation: Computed tomography
Follow-up computed tomography at 3-6 months and 12 months
Other Names:
  • Pulmonary function test
  • Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The magnitude of pulmonary involvement
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
results of respiratory function testing
Time Frame: 12 months
12 months
echocardiographic parameters
Time Frame: 12 months
12 months
persistence of symptoms
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Gabriele Fragasso, MD, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 16, 2024

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET 145-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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