Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-29 @ 8:20 PM
Study NCT ID:
NCT05062603
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Changes in Covid 19 Patients Discharged From Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], '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': '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': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of lung ultrasound changes over the time period of follow up.', 'timeFrame': 'Approximately 3 months or until the ultrasound changes in the lung had normalised', 'description': 'The assessment will determine how long it takes for lung ultrasound changes to resolve following discharge from hospital in patients who were diagnosed with COVID-19 (unit of measurement: days).'}], 'secondaryOutcomes': [{'measure': 'Exploration of ongoing symptoms', 'timeFrame': 'Approximately 3 months or until the ultrasound changes in the lung had normalised', 'description': 'Ongoing symptoms will be explored by using screening questions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'COVID-19', 'Lung ultrasound', 'Respiratory'], 'conditions': ['Covid19', 'Coronavirus', 'Coronavirus Infection', 'SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '32109013', 'type': 'BACKGROUND', 'citation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.'}, {'pmid': '32167853', 'type': 'BACKGROUND', 'citation': 'Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Huang Yi, Sihan Wangm Yue Liu, Yaohui Zhang, Chuyun Zheng, Yu Zheng, CHaoyang Zhangm et al. A preliminary study on the ultrasonic manifestations of Peripulmonary lesions of non-critical Novel Coronavirus Pneumonia (Covid-19).'}, {'pmid': '32166346', 'type': 'BACKGROUND', 'citation': 'Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Lung ultrasound has been used to help diagnose COVID-19 as an alternative to CT scanning and chest X-ray. CT scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues.\n\nChest X-ray misses up to 40% of COVID diagnoses. Although lung ultrasound can diagnose, the investigators do not know how long these lung ultrasound changes last. The investigators would like to follow up patients to characterise the pattern of changes and how long they last. This is particularly important given a potential second surge of COVID-19 is looming and the investigators would like to know if lung ultrasound changes are new or old in patients presenting during this second wave and in the future.', 'detailedDescription': 'Ultrasound has been invaluable during this pandemic to diagnose COVID-19. The investigators have used it alongside CT scanning to rationalise the number of CT scans especially when patients are unstable. The investigators do not know how long these changes last on lung ultrasound after discharge and the investigators wish to study this.\n\nThis is because patients will start presenting shortly who have a history of COVID-19 with acute medical problems and if the investigators are to use lung ultrasound again the investigators would like to know whether the changes the investigators see are new or old.\n\nThis is vitally important before a second surge and especially so before winter. This may also facilitate triage of patients from the front door in the Emergency department to different areas (such as COVID-19 zones or clean areas).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with a confirmed COVID-19 viral infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Confirmed COVID-19 positive with changes on CXR or CT scan\n* Having had an initial lung ultrasound in the Emergency department when they were first admitted into the hospital.\n\nExclusion Criteria:\n\n* Pre-existing lung disease\n* Heart failure\n* Under 18 years old.'}, 'identificationModule': {'nctId': 'NCT05062603', 'briefTitle': 'Lung Ultrasound Changes in Covid 19 Patients Discharged From Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Chelsea and Westminster NHS Foundation Trust'}, 'officialTitle': 'Prospective Observational Study Looking at Lung Ultrasound Changes During Recovery From COVID19 Infection', 'orgStudyIdInfo': {'id': 'C&W20/036'}, 'secondaryIdInfos': [{'id': 'IRAS number 286015', 'type': 'OTHER', 'domain': 'Integrated Research Application System'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Paramjeet Deol, MBChB FRCEM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea and Westminster NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}