Covid19NCT04544176
COVID-19 Risk From Attending Outpatient Radiology Appointments
An observational study of Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Observational
- How many people
- 48,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals, NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Determining the Risk of Developing Symptomatic SARS-COV2-19 Infection After Attending Hospital for Radiological Examinations: a Controlled Cohort Study
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.
Read the detailed description
Since March 2020, the novel coronavirus (COVID-19) pandemic has caused considerable disruption to the provision of routine healthcare in the UK. A key priority for healthcare providers when gaining control of COVID-19, is to restart the provision of urgent non-COVID care. There are several barriers including a reluctance for people to attend hospital appointments for fears of contracting COVID-19. Although SARS-COV2 infections have been reported to occur during hospital inpatient stay, the risk of acquiring SARS-COV2 during outpatient consultations or radiological investigations has not been reported.
In a pilot study at our hospitals during the pandemic, we have found radiology to reliably record in person attendance contrary to outpatient clinic appointments records that were contaminated by remote consultations. The investigators will calculate the incidence of infection in approximately 30,000 patients at Nottingham and 17,000 patients at Cardiff and calculate the risk of infection within 28 days of attending outpatient radiology appointments. Controls will use data on patients who attended the hospitals in 2019.
The study team will utilize the data held in the electronic systems of NUH and University Hospital of Wales to perform a cohort study which will comprise both an exposed cohort and unexposed cohort.
The exposed cohort will comprise patients who attended outpatient radiology appointments during (between 29/1/20 - 24/5/20) and whether they subsequently developed a positive or negative PCR test for Sars-CoV2 result within 28-days of their attendance. The unexposed cohort will work as a control group, comprising individuals who attended outpatient radiology appointments during the equivalent period in 2019.
All of this data will be retrospective, so will not require any additional data collection, nor will it interfere with routine clinical care. Pseudo-anonymised data will be transferred from University Hospital of Wales in Cardiff to Nottingham University Hospitals (NUH) Trust via a password-protected, encrypted spreadsheet, with original patient identifiers removed, and a unique code assigned, that only the researcher in Cardiff can use to trace back to the individual, this is so all the analysis can be performed at NUH by a Nottingham based statistician.
The study team consisting of clinicians, data analysts, epidemiologist and clinical researchers will analyse this information to quantify the risk of infection which will help inform the recovery plans and service provision during the restart of urgent and routine non-COVID care.
- Conditions
- Covid19
- Being tested
- Observational
- Keywords
- Radiology, Outpatient, Hospital
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
There will be no interventions in this study, it is purely observational using data already collected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
A microbiological diagnosis of COVID infection.
Information will be collected on patients who receive a positive or negative COVID-19 test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Wales
- Responsible party
- Sponsor
- Investigators
- Nikos Evangelou, FRCP, DPhil (Oxon), Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544176
- Sponsor's protocol ID
- 20NS031
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Risk of Developing Symptomatic SARS-COV2-19 Infection After Attending Hospital for Radiological Examinations: a Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT04544176
- Acronym / sponsor ID
- 20NS031
- Conditions
- Covid19
- Keywords
- Radiology, Outpatient, Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48,000 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University Hospital of Wales
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since March 2020, the novel coronavirus (COVID-19) pandemic has caused considerable disruption to the provision of routine healthcare in the UK. A key priority for healthcare providers when gaining control of COVID-19, is to restart the provision of urgent non-COVID care. There are several barriers including a reluctance for people to attend hospital appointments for fears of contracting COVID-19. Although SARS-COV2 infections have been reported to occur during hospital inpatient stay, the risk of acquiring SARS-COV2 during outpatient consultations or radiological investigations has not been reported.
In a pilot study at our hospitals during the pandemic, we have found radiology to reliably record in person attendance contrary to outpatient clinic appointments records that were contaminated by remote consultations. The investigators will calculate the incidence of infection in approximately 30,000 patients at Nottingham and 17,000 patients at Cardiff and calculate the risk of infection within 28 days of attending outpatient radiology appointments. Controls will use data on patients who attended the hospitals in 2019.
The study team will utilize the data held in the electronic systems of NUH and University Hospital of Wales to perform a cohort study which will comprise both an exposed cohort and unexposed cohort.
The exposed cohort will comprise patients who attended outpatient radiology appointments during (between 29/1/20 - 24/5/20) and whether they subsequently developed a positive or negative PCR test for Sars-CoV2 result within 28-days of their attendance. The unexposed cohort will work as a control group, comprising individuals who attended outpatient radiology appointments during the equivalent period in 2019.
All of this data will be retrospective, so will not require any additional data collection, nor will it interfere with routine clinical care. Pseudo-anonymised data will be transferred from University Hospital of Wales in Cardiff to Nottingham University Hospitals (NUH) Trust via a password-protected, encrypted spreadsheet, with original patient identifiers removed, and a unique code assigned, that only the researcher in Cardiff can use to trace back to the individual, this is so all the analysis can be performed at NUH by a Nottingham based statistician.
The study team consisting of clinicians, data analysts, epidemiologist and clinical researchers will analyse this information to quantify the risk of infection which will help inform the recovery plans and service provision during the restart of urgent and routine non-COVID care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Other: ObservationalThis 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. |
| Unexposed Cohort | – | Other: ObservationalThis 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThere will be no interventions in this study, it is purely observational using data already collected. | Other | Exposed Cohort, Unexposed Cohort |
Primary outcome
A microbiological diagnosis of COVID infection.
Time frame: 6 months
Information will be collected on patients who receive a positive or negative COVID-19 test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikos Evangelou, FRCP, DPhil (Oxon) principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A microbiological diagnosis of COVID infection. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.