NCT04473105

Brief Summary

The investigators plan to use all of the information available within their local NHS hospitals Trust to work out what happens to people admitted with both suspected and proven Covid-19 infections. The investigators will use all of the information that they can to provide the most evidence possible to use in their investigation as this will make the results more accurate. This will include information on existing health conditions (e.g. by looking at previous discharge letters, GP summaries), clinical observations recorded in the hospital (e.g. temperature, blood pressure, pulse, oxygen levels) and laboratory measures (e.g. blood markers of infection). The investigators experienced team will then analyse all of this together with information about whether the person has Covid-19 to help work out what any new patients' risk will be. To do this the investigators need to use individual patients' information, however once removed from the hospital records system it will not be identifiable and will be held securely within the hospital at all times. As a result of this work the investigators plan to be able to do two things:

  1. 1.When a patient is admitted to hospital with possible or confirmed Covid-19 the investigators will be able to make a highly accurate prediction of what is likely to happen to them (e.g. being admitted to high dependency or intensive care, dying or surviving to discharge) which will help health care professional make decisions about their care.
  2. 2.By knowing what is likely to happen to a patient the investigators are able to make informed decisions about how to distribute healthcare resources e.g. which areas are likely to need more ventilators (machines to help with breathing), need for intensive care beds, discharge planning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

May 20, 2020

Last Update Submit

April 8, 2024

Conditions

Keywords

prognostic scoreventilationmortalityearly discharge

Outcome Measures

Primary Outcomes (1)

  • Ventilation

    The need to ventilate the patient

    During admission up to 3 months

Secondary Outcomes (1)

  • Death

    During admission or within 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients meeting above criteria during the study period and prior to it for whom follow up to 30 days can be completed during the period (i.e. admissions until 30 days prior to study closes)

You may qualify if:

  • All patients admitted to Nottingham University Hospitals Trust either suspected of having Covid-19 infection or in whom the diagnosis is eventually confirmed and who are over the age of 18 years

You may not qualify if:

  • Aged under 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Timothy R Card, FRCP, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 20, 2020

First Posted

July 16, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations