Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT04916834
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Lung transfer factor for carbon monoxide (TL,CO) will be measured using single breath method, results will be reported as absolute values (mmol/min/kPa)'}, {'measure': 'Change from baseline in lung transfer factor for carbon monoxide (TL,CO) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Lung transfer factor for carbon monoxide (TL,CO) will be measured using single breath method, results will be reported as % of predicted using GLI-2017 references'}, {'measure': 'Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as absolute values (L)'}, {'measure': 'Change from baseline in forced vital capacity (FVC) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Forced vital capacity (FVC) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as % of predicted using GLI-2012 references'}, {'measure': 'Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as absolute values (L)'}, {'measure': 'Change from baseline in forced expiratory volume at 1 second (FEV1) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Forced expiratory volume at 1 second (FEV1) will be measured using spirometry according to ATS/ERS 2019 guidelines, results will be reported as % of predicted using GLI-2012 references'}, {'measure': 'Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 guidelines, results will be reported as absolute values (L)'}, {'measure': 'Change from baseline in total lun capacity (TLC) at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Total lung capacity will be measured using body plethysmography method according to ATS/ERS 2005 guidelines, results will be reported as % of predicted using most recent references'}, {'measure': 'Change in prevalence of abnormal (low) lung transfer factor for carbon monoxide (TL,CO) results at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Abnormal (low) lung transfer factor for carbon monoxide (TL,CO) will be identified with cut-off point at the level of 5th percentile (-1.64 SD) using most recent predicted values (GLI-2017), prevalence will be reported as % of investigated group'}, {'measure': 'Change in prevalence of obstructive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Obstructive ventilatory impairment (airway obstruction) will be identified with FEV1/FVC ratio below lower limit of normal, cut-off point at the level of 5th percentile (-1.64 SD) will be used with most recent predicted values (GLI-2012), prevalence will be reported as % of investigated group'}, {'measure': 'Change in prevalence of restrictive ventilatory impairment at 3, 6 and 12 months after COVID-19 pneumonia', 'timeFrame': '0, 3, 6, 12 months after COVID-19 pneumonia', 'description': 'Restrictive ventilatory impairment will be identified with total lung capacity (TLC) below lower limit of normal, cut-off point at the level of 5th percentile (-1.64 SD) will be used with most recent predicted values, prevalence will be reported as % of investigated group'}, {'measure': 'Change in lung structure from the baseline', 'timeFrame': '3, 6, 12 months', 'description': 'Change in lung structure will be assessed using high resolution computed tomography (HRCT) performed at 3, 6 and 12 months after initial investigation. Quantitive assessment of abnormalities will be performed and compared with initial investigation performed during acute phase of COVID-19 pneumonia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'SARS-CoV Infection', 'Pulmonary Function', 'Pneumonia, Viral']}, 'descriptionModule': {'briefSummary': 'Prospective study in a group of patients with COVID-19 pneumonia.', 'detailedDescription': 'Objective:\n\nAssessment of pulmonary and heart dysfunction, fibrosis-related markers and antibodies as well as the search for risk factors for an unfavorable course and possible complications in patients after pneumonia due to SARS-CoV-2 (COVID-19) infection.\n\nPatients:\n\nA group of approx. 100 patients assessed shortly after pneumonia and followed up, investigated after 3 and 6 months with possible prolongation to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients dicharged after confirmed COVID-19 pneumonia (positive PCR and lung involvement in HRCT, hospitalized)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed SARS-CoV-2 infection with pneumonia hospitalized\n2. Two negative PCR results of a swab from the respiratory tract in succession, including the last one taken no later than 3 days before the planned lung function tests (1st visit).\n\nExclusion Criteria:\n\n1. Lack of patient consent,\n2. Present contraindications for lung function tests\n3. Inability to perform correctly lung function measurements'}, 'identificationModule': {'nctId': 'NCT04916834', 'briefTitle': 'Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.', 'organization': {'class': 'OTHER', 'fullName': 'National Institute for Tuberculosis and Lung Diseases, Poland'}, 'officialTitle': 'Impact of SARS-CoV-2/COVID-19 Related Pneumonia on Lung Function and Structure - Prospective Case Control Study', 'orgStudyIdInfo': {'id': 'IGICHP/7.52'}}, 'contactsLocationsModule': {'locations': [{'zip': '01-138', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'National Institute for Tuberculosis and Lung Diseases', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Piotr W Boros, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National TB & Lung Diseases Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute for Tuberculosis and Lung Diseases, Poland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}