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Case Fatalities in Hospitalised COVID-19 Patients in the UK

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
Recruitment Status : Completed
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
International Severe Acute Respiratory and Emerging Infection Consortium
BREATHE Health Data Research Hub
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Other: Patient Characteristics Other: COVID-19 treatments Other: Differences in triage Other: Surge capacity

Study Design
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Study Type : Observational
Actual Enrollment : 70000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study
Actual Study Start Date : February 24, 2020
Actual Primary Completion Date : August 2, 2020
Actual Study Completion Date : August 2, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Hospitalisations
All hospitalised COVID patients
 Other: Patient Characteristics
Characteristics of the patients

Other: COVID-19 treatments
Specific treatments used on COVID-19 patients

Other: Differences in triage
Triage criteria for treating COVID-19 patients

Other: Surge capacity
Capacity of hospitals
Critical care
All hospitalised COVID patients in critical care
 Other: Patient Characteristics
Characteristics of the patients

Other: COVID-19 treatments
Specific treatments used on COVID-19 patients

Other: Differences in triage
Triage criteria for treating COVID-19 patients

Other: Surge capacity
Capacity of hospitals


Outcome Measures
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Primary Outcome Measures :
  1. Case fatality [ Time Frame: 23 weeks ]
    The proportion of new admissions with COVID-19 who died over time


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • All patients admitted with a proven or high likelihood of COVID-19
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527458


Locations
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United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
University of Edinburgh
International Severe Acute Respiratory and Emerging Infection Consortium
BREATHE Health Data Research Hub
Investigators
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Principal Investigator: Annemarie B Docherty Usher Institute, University of Edinburgh
Principal Investigator: Ewen M Harrison Usher Institute, University of Edinburgh
Principal Investigator: Rachel H Mulholland Usher Institute, University of Edinburgh
More Information
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Additional Information:

Publications:

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04527458    
Other Study ID Numbers: ISARIC_COVID_CF
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
COVID-19
ISARIC
Hospitalisations
 Mortality
Case fatality
United Kingdom
Additional relevant MeSH terms:
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COVID-19
Death
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes