Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT04351802
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of COVID-19 on lung ultrasound', 'timeFrame': 'On day of admission to hospital', 'description': 'Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound'}, {'measure': 'Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray', 'timeFrame': 'On day of admission to hospital', 'description': 'Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray', 'timeFrame': 'On day of admission to hospital', 'description': 'Primary and blinded scorer diagnosis of alternative condition on lung ultrasound'}, {'measure': 'Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19', 'timeFrame': 'During hospital admission', 'description': 'Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirements'}, {'measure': 'Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19', 'timeFrame': 'On day of admission to hospital', 'description': 'Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Lung Ultrasound'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.", 'detailedDescription': 'Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.\n\nParticipants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.\n\nParticipants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Suspected or confirmed diagnosis of COVID-19\n* Able to provide informed consent to study participation\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Inability to provide informed consent at the time of study enrolment'}, 'identificationModule': {'nctId': 'NCT04351802', 'acronym': 'COR-DLUS', 'briefTitle': 'CORonavirus (COVID-19) Diagnostic Lung UltraSound Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'CORonavirus (COVID-19) Diagnostic Lung UltraSound Study', 'orgStudyIdInfo': {'id': '282661'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Focused lung ultrasound examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'John P Corcoran, BMBCh MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Plymouth NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}