Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT04933994
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of COVID-19 and H1N1 Influenza Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-20', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the clinical and CT features between COVID-19 pneumonia and H1N1 influenza pneumonia in Zhejiang, China', 'timeFrame': '1 year', 'description': 'one paper'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COVID-19, H1N1, Tomography, X-ray computed'], 'conditions': ['COVID-19', 'H1N1 Influenza']}, 'descriptionModule': {'briefSummary': 'To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia.', 'detailedDescription': 'COVID-19 pneumonia patients showed less proportions of underlying diseases, fever and respiratory symptoms than those of H1N1 pneumonia patients (p\\<0.01). White blood cell count, neutrophilic granulocyte percentage, C-reactive protein, procalcitonin, D-Dimer and lactate dehydrogenase in H1N1 pneumonia patients were higher than those of COVID-19 pneumonia patients (p\\<0.05). H1N1 pneumonia were often symmetrically located in the dorsal part of lung inferior lobes, while COVID-19 pneumonia were unsually showed a peripheral but non-specific lobe distributions. Ground glass opacity was more common in COVID-19 pneumonia and consolidation lesions was more common in H1N1 pneumonia (p\\<0.01). COVID-19 pneumonia lesions showed a relative clear margin compared with H1N1 pneumonia. Crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions were more common in COVID-19 pneumonia than H1N1 pneumonia (p\\<0.05). Pleural effusion in COVID-19 pneumonia was significantly less common than H1N1 pneumonia (p\\<0.01).\n\nCompared with H1N1 pneumonia in Zhejiang, China, the clinical manifestations of COVID-19 pneumonia was more concealed with less underlying diseases and slighter respiratory symptoms. The more common CT manifestations of COVID-19 pneumonia included ground glass opacity with a relative clear margin, crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions, while the less common CT manifestations of COVID-19 pneumonia included consolidation and pleural effusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pneumonia with COVID-19 pneumonia or H1N1 influenza', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pneumonia\n\nExclusion Criteria:\n\n* no pneumonia'}, 'identificationModule': {'nctId': 'NCT04933994', 'briefTitle': 'Comparison of COVID-19 and H1N1 Influenza Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Comparison of the Clinical and CT Features Between COVID-19 Pneumonia and H1N1 Influenza Pneumonia in Zhejiang, China', 'orgStudyIdInfo': {'id': '2021-0187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronavirus disease; Influenza A(H1N1)', 'description': 'two independent cohorts of COVID-19 pneumonia (n=405) and H1N1 influenza pneumonia (n=78) retrospectively, all patients were confirmed by RT-PCR. Four hundred and five cases of COVID-19 pneumonia were confirmed in nine hospitals of Zhejiang province, China from January 21 to February 20, 2020. Seventy-eight cases of H1N1 influenza pneumonia were confirmed in our hospital from January 1, 2017 to February 29, 2020.', 'interventionNames': ['Device: computed Tomography']}], 'interventions': [{'name': 'computed Tomography', 'type': 'DEVICE', 'description': 'All cases were detected with computed Tomography', 'armGroupLabels': ['Coronavirus disease; Influenza A(H1N1)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': "Yueqing People's Hospital of Zhejiang Province", 'class': 'UNKNOWN'}, {'name': 'Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University', 'class': 'OTHER'}, {'name': "Ruian People's Hospital of Zhejiang Province", 'class': 'UNKNOWN'}, {'name': "The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, {'name': "Kecheng People's Hospital of Quzhou city, Zhejiang Province", 'class': 'UNKNOWN'}, {'name': "Pingyang People's Hospital of Zhejiang Province", 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Yuhang District, Hangzhou, Zhejiang Province", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}