Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04524520
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical', 'timeFrame': 'through study completion , an average of 1 year', 'description': 'Chelsea critical care physical assessment tool'}, {'measure': 'Physical', 'timeFrame': 'through study completion , an average of 1 year', 'description': 'Incremental Shuttle Walk Test (ISWT)'}, {'measure': 'Physical', 'timeFrame': 'through study completion , an average of 1 year', 'description': '1- minute Sit to Stand, Grip strength'}, {'measure': 'Health Related Quality of life', 'timeFrame': 'at 3 months', 'description': 'Short Form Survey on health related quality of life (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Higher scores indicate better outcome.'}, {'measure': 'Health Related Quality of life', 'timeFrame': 'at 1 year', 'description': 'Short Form Survey on health related quality of life (SF-36). Scores can range from 0 to 100 and a higher score indicates better outcome.'}, {'measure': 'Psychological', 'timeFrame': 'through study completion , an average of 1 year', 'description': 'Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.'}, {'measure': 'Psychological', 'timeFrame': 'through study completion , an average of 1 year', 'description': 'Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.'}, {'measure': 'Psychological', 'timeFrame': 'through study completion , an average of 1 year', 'description': 'Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.'}, {'measure': 'Psychological', 'timeFrame': 'at 1 year', 'description': "Post-traumatic stress disorder (PTSD) Trauma Screening (TSQ). A screening tool with 10 items. If 6 items are endorsed then the outcome is 'positive' for PTSD."}], 'secondaryOutcomes': [{'measure': 'risk stratification', 'timeFrame': 'through study completion and average of 1 year', 'description': 'escalation to critical care (Yes/No)'}, {'measure': 'risk stratification', 'timeFrame': 'through study completion and average of 1 year', 'description': 'mechanical ventilation (Yes/No)'}, {'measure': 'risk stratification', 'timeFrame': 'through study completion and average of 1 year', 'description': 'critical care stay hospital stay (number of days)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients']}, 'descriptionModule': {'briefSummary': 'A novel coronavirus, designated corona virus disease 2019 (COVID-19) has resulted in a Pandemic at the time of writing (27th April) the reported number of confirmed cases exceeding 3 million and over 200000 associated deaths.\n\nThe burden on global critical care has been considerable. As of 24th April there have been 8752 UK critical care admissions with services under considerable strain, and a mortality rate over 50%. Survivors of critical illness will require significant input.\n\nThis study will perform mixed methods to provide rich data on risk stratification and recovery from critical illness. Recovery from a novel disease requires documenting and the study reports physical and psychological changes following hospital discharge in survivors. In addition qualitative interviews are being conducted with patients who have survived and been discharged from critical care along with their relatives and treating professionals, to better understand their needs during recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults admitted to hospital with suspected/confirmed COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived\n2. Relatives or friends and professionals involved in the care of these patients.\n\nExclusion Criteria:\n\n1. Patients \\<18 years;\n2. Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;'}, 'identificationModule': {'nctId': 'NCT04524520', 'briefTitle': 'COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Western Sussex Hospitals NHS Trust'}, 'officialTitle': 'COVID19-OR (SARS-CoV-2):Observation, Risk & Recovery. An Observational Study Exploring Risk Assessment and Recovery From COVID-19 (SARS-CoV-2) Infection in Hospitalised Patients', 'orgStudyIdInfo': {'id': '20/YH/0157'}}, 'contactsLocationsModule': {'locations': [{'city': 'Worthing', 'country': 'United Kingdom', 'facility': 'Dr Luke Hodgson', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'overallOfficials': [{'name': 'Dr Luke Hodgson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Sussex Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Sussex Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}