Case Fatalities in Hospitalised COVID-19 Patients in the UK
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04527458 |
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Recruitment Status :
Completed
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
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Sponsor:
University of Edinburgh
Collaborators:
International Severe Acute Respiratory and Emerging Infection Consortium
BREATHE Health Data Research Hub
Information provided by (Responsible Party):
University of Edinburgh
| Tracking Information | ||||||||||
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| First Submitted Date | August 24, 2020 | |||||||||
| First Posted Date | August 26, 2020 | |||||||||
| Last Update Posted Date | August 26, 2020 | |||||||||
| Actual Study Start Date | February 24, 2020 | |||||||||
| Actual Primary Completion Date | August 2, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Case fatality [ Time Frame: 23 weeks ] The proportion of new admissions with COVID-19 who died over time
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Case Fatalities in Hospitalised COVID-19 Patients in the UK | |||||||||
| Official Title | Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study | |||||||||
| Brief Summary | 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | All patients with proven or high likelihood of COVID-19 admitted to the 260 UK hospitals enrolled in the ISARIC-4C study | |||||||||
| Condition | Covid19 | |||||||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
70000 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Actual Study Completion Date | August 2, 2020 | |||||||||
| Actual Primary Completion Date | August 2, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | United Kingdom | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT04527458 | |||||||||
| Other Study ID Numbers | ISARIC_COVID_CF | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | University of Edinburgh | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | University of Edinburgh | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Edinburgh | |||||||||
| Verification Date | August 2020 | |||||||||