Pulmonary Fibrosis After Severe COVID-19 Pneumonia

NCT06423560 | Completed

• 1 other identifier: CET 145-2024
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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

Pulmonary Fibrosis; COVID-19

Keywords

COVID-19; Pulmonary fibrosis; ARDS; Computed tomography; pulmonary function test

Outcome Measures

Primary Outcomes (1)

• The magnitude of pulmonary involvement

  12 months

Secondary Outcomes (3)

• results of respiratory function testing

  12 months

• echocardiographic parameters

  12 months

• persistence of symptoms

  12 months

Study Arms (2)

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

Radiation: Computed tomography

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

Radiation: Computed tomography

Interventions

Computed tomography RADIATION

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

Also known as: Pulmonary function test, Echocardiography

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18
• Absence of previously cited test.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, Lombardy, 20132, Italy

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; COVID-19

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Gabriele Fragasso, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: May 16, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

IT (1)