Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-05 @ 12:38 AM
Study NCT ID:
NCT06423560
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Fibrosis After Severe COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}], 'ancestors': [{'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The magnitude of pulmonary involvement', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'results of respiratory function testing', 'timeFrame': '12 months'}, {'measure': 'echocardiographic parameters', 'timeFrame': '12 months'}, {'measure': 'persistence of symptoms', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Pulmonary fibrosis', 'ARDS', 'Computed tomography', 'pulmonary function test'], 'conditions': ['Pulmonary Fibrosis', 'COVID-19']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Hospitalization for severe COVID-19 pneumonia\n* Computed tomography during index hospitalization that showed: (i) normale lung parenchyma \\< 50% of total lung volume and/or (ii) parenchymal consolidation \\> 10%\n* Cardiological and pneumological visit, echocardiography and pulmonary function test at 3 and 12 months from hospital discharge\n* Computed tomography by 12 months from hospital discharge\n\nExclusion Criteria:\n\n* Age \\< 18\n* Absence of previously cited test.'}, 'identificationModule': {'nctId': 'NCT06423560', 'acronym': 'SPIFFERO', 'briefTitle': 'Pulmonary Fibrosis After Severe COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)', 'orgStudyIdInfo': {'id': 'CET 145-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Residual disease > 20% of the total lung volume was considered pathological at follow-up CT', 'interventionNames': ['Radiation: Computed tomography']}, {'label': 'Residual disease < 20% of the total lung volume was considered pathological at follow-up CT', 'interventionNames': ['Radiation: Computed tomography']}], 'interventions': [{'name': 'Computed tomography', 'type': 'RADIATION', 'otherNames': ['Pulmonary function test', 'Echocardiography'], 'description': 'Follow-up computed tomography at 3-6 months and 12 months', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Gabriele Fragasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabriele Fragasso', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}