- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527458
Case Fatalities in Hospitalised COVID-19 Patients in the UK
August 24, 2020 updated by: University of Edinburgh
Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Edinburgh, United Kingdom
- University of Edinburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- All patients admitted with a proven or high likelihood of COVID-19
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospitalisations
All hospitalised COVID patients
|
Characteristics of the patients
Specific treatments used on COVID-19 patients
Triage criteria for treating COVID-19 patients
Capacity of hospitals
|
|
Critical care
All hospitalised COVID patients in critical care
|
Characteristics of the patients
Specific treatments used on COVID-19 patients
Triage criteria for treating COVID-19 patients
Capacity of hospitals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Case fatality
Time Frame: 23 weeks
|
The proportion of new admissions with COVID-19 who died over time
|
23 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 24, 2020
Primary Completion (ACTUAL)
August 2, 2020
Study Completion (ACTUAL)
August 2, 2020
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (ACTUAL)
August 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 26, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISARIC_COVID_CF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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