NCT04838106

Brief Summary

This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
319,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 14, 2024

Status Verified

July 1, 2024

Enrollment Period

4.6 years

First QC Date

April 7, 2021

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality Rate

    Mortality after discharge from hospital

    One year

Secondary Outcomes (5)

  • Rate of emergency hospital admission

    one year

  • Rate of emergency hospital admission for respiratory infection

    one year

  • Rate of emergency hospital admission for a major adverse cardiac event

    one year

  • Rate of emergency hospital admission for a venous thrombotic event

    one year

  • Rate of development of end stage renal failure

    one year

Study Arms (2)

Covid19

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020.

Other: Not applicable as observational study

Non Covid19

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020.

Other: Not applicable as observational study

Interventions

Not applicable as observational study.

Covid19Non Covid19

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge.

You may qualify if:

  • Age 16 years or over
  • Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
  • Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-

You may not qualify if:

  • Patients who died in hospital after treatment on an ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

COVID-19Myocardial InfarctionStrokeCritical IllnessHeart FailureVenous ThrombosisPulmonary EmbolismRenal Insufficiency

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesThrombosisEmbolism and ThrombosisEmbolismKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Peter Watkinson, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 8, 2021

Study Start

August 1, 2020

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

August 14, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available due to privacy and legal implications.

Locations