Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT04527458
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2020-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Case Fatalities in Hospitalised COVID-19 Patients in the UK
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093485', 'term': 'COVID-19 Drug Treatment'}, {'id': 'D014218', 'term': 'Triage'}, {'id': 'D055872', 'term': 'Surge Capacity'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004632', 'term': 'Emergency Medical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D006301', 'term': 'Health Services Needs and Demand'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Case fatality', 'timeFrame': '23 weeks', 'description': 'The proportion of new admissions with COVID-19 who died over time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'ISARIC', 'Hospitalisations', 'Mortality', 'Case fatality', 'United Kingdom'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32444460', 'type': 'BACKGROUND', 'citation': 'Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.'}], 'seeAlsoLinks': [{'url': 'https://isaric4c.net/', 'label': 'ISARIC 4C website'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with proven or high likelihood of COVID-19 admitted to the 260 UK hospitals enrolled in the ISARIC-4C study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted with a proven or high likelihood of COVID-19'}, 'identificationModule': {'nctId': 'NCT04527458', 'briefTitle': 'Case Fatalities in Hospitalised COVID-19 Patients in the UK', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study', 'orgStudyIdInfo': {'id': 'ISARIC_COVID_CF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalisations', 'description': 'All hospitalised COVID patients', 'interventionNames': ['Other: Patient Characteristics', 'Other: COVID-19 treatments', 'Other: Differences in triage', 'Other: Surge capacity']}, {'label': 'Critical care', 'description': 'All hospitalised COVID patients in critical care', 'interventionNames': ['Other: Patient Characteristics', 'Other: COVID-19 treatments', 'Other: Differences in triage', 'Other: Surge capacity']}], 'interventions': [{'name': 'Patient Characteristics', 'type': 'OTHER', 'description': 'Characteristics of the patients', 'armGroupLabels': ['Critical care', 'Hospitalisations']}, {'name': 'COVID-19 treatments', 'type': 'OTHER', 'description': 'Specific treatments used on COVID-19 patients', 'armGroupLabels': ['Critical care', 'Hospitalisations']}, {'name': 'Differences in triage', 'type': 'OTHER', 'description': 'Triage criteria for treating COVID-19 patients', 'armGroupLabels': ['Critical care', 'Hospitalisations']}, {'name': 'Surge capacity', 'type': 'OTHER', 'description': 'Capacity of hospitals', 'armGroupLabels': ['Critical care', 'Hospitalisations']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Annemarie B Docherty', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Usher Institute, University of Edinburgh'}, {'name': 'Ewen M Harrison', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Usher Institute, University of Edinburgh'}, {'name': 'Rachel H Mulholland', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Usher Institute, University of Edinburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Access to all data and samples collected by ISARIC4C are controlled by an Independent Data and Materials Access Committee (IDAMAC), composed of representatives of research funders, academia, clinical medicine, public health and industry. Their job is to ensure that all data and samples are used to generate the greatest possible benefit to humanity, in the shortest possible time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Severe Acute Respiratory and Emerging Infection Consortium', 'class': 'OTHER'}, {'name': 'BREATHE Health Data Research Hub', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}