NCT04544176

Brief Summary

By using recent data on hospital attendance and COVID-19 laboratory tests, available within two NHS trusts in Nottingham and Cardiff we will enable the calculation of the risk of developing COVID-19 infection after attending an outpatient hospital appointment. This will assist in the restart planning when resuming face to face outpatient radiology appointment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

September 9, 2020

Last Update Submit

February 9, 2021

Conditions

Keywords

RadiologyOutpatientHospital

Outcome Measures

Primary Outcomes (1)

  • A microbiological diagnosis of COVID infection.

    Information will be collected on patients who receive a positive or negative COVID-19 test.

    6 months

Study Arms (2)

Exposed Cohort

This group will include patients attending radiology outpatient appointments in 2020 in our period of interest from the peak of the first wave of the pandemic, who were subsequently tested for SARS-COV2 within 28-days of their attendance.

Other: Observational

Unexposed Cohort

This group will form the control group and comprises all individuals who attended radiological appointments during the same period for each hospital in 2019 but not 2020.

Other: Observational

Interventions

There will be no interventions in this study, it is purely observational using data already collected.

Exposed CohortUnexposed Cohort

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals attending outpatient clinics will be included for analysis, this is anticipated this to be in excess of 30,000 patients at NUH and around 17,000 patients at Cardiff. To ensure a substantive number of patients are included for analysis and comparison across the UK, 2 large hospitals (Nottingham University Hospitals and Cardiff University Hospitals) will be participating in this study.

You may qualify if:

  • Exposed Cohort: outpatient radiology attendance at NUH between 29/1/20 - 24/5/20 or at University Hospital of Wales, Cardiff between 7/3/20 - 11/5/20.
  • Unexposed Cohort: outpatient attendance outpatient attendance at NUH between 29/1/19 - 24/5/19 or at University Hospital of Wales, Cardiff between 7/3/19 - 11/5/19.

You may not qualify if:

  • Patients who had an inpatient stay in the previous 28-days but excluding the 2 days prior to the SARS-COV2 test Radiological examinations that were part of an inpatient stay were not considered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals, NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Nikos Evangelou, FRCP, DPhil (Oxon)

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 10, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

January 1, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations