NCT04527458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 24, 2020

Last Update Submit

August 24, 2020

Conditions

Keywords

COVID-19ISARICHospitalisationsMortalityCase fatalityUnited Kingdom

Outcome Measures

Primary Outcomes (1)

  • Case fatality

    The proportion of new admissions with COVID-19 who died over time

    23 weeks

Study Arms (2)

Hospitalisations

All hospitalised COVID patients

Other: Patient CharacteristicsOther: COVID-19 treatmentsOther: Differences in triageOther: Surge capacity

Critical care

All hospitalised COVID patients in critical care

Other: Patient CharacteristicsOther: COVID-19 treatmentsOther: Differences in triageOther: Surge capacity

Interventions

Characteristics of the patients

Critical careHospitalisations

Specific treatments used on COVID-19 patients

Critical careHospitalisations

Triage criteria for treating COVID-19 patients

Critical careHospitalisations

Capacity of hospitals

Critical careHospitalisations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • All patients admitted with a proven or high likelihood of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32444460BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Drug TreatmentTriageSurge Capacity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsEmergency Medical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Services Needs and DemandDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 26, 2020

Study Start

February 24, 2020

Primary Completion

August 2, 2020

Study Completion

August 2, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

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.

Locations