Skip to main content
OpenTrials
Completed

NCT Number: NCT06423560

Pulmonary Fibrosis After Severe COVID-19 Pneumonia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Fibrosis COVID-19 Coronaviridae Infections Coronavirus Infections Fibrosis Infections Lung Diseases Lung Diseases, Interstitial Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, Lombardy, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

computed tomography

Radiation

Follow-up computed tomography at 3-6 months and 12 months

Other names: Pulmonary function test, Echocardiography

Primary outcomes

  1. The magnitude of pulmonary involvement

    Time frame: 12 months

Secondary outcomes

  1. results of respiratory function testing

    Time frame: 12 months

  2. echocardiographic parameters

    Time frame: 12 months

  3. persistence of symptoms

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: SPIFFERO

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.