Condition category
Infections and Infestations
Date applied
17/03/2020
Date assigned
18/03/2020
Last edited
18/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is caused by a virus that infects the respiratory tract of people and makes them unwell. It started in a city in China and has now spread to several other countries around the world, including the United Kingdom. There is no vaccine or treatment for COVID-19 at the moment and governments are trying hard to stop it from spreading by making sure that infected people are identified as soon as possible and kept away from others. To know who has the infection you need to do a test and at the moment this is done in large laboratories within hospitals. Although laboratory testing is accurate, it takes a long time to get results back, leading to long delays in identifying positive cases and in identifying patients who are negative. Companies have developed tests for COVID-19 that can be performed outside of the laboratory and take just one hour to give a result. Having a rapid test result may allow doctors to identify infected patients much more rapidly and to stop the virus from spreading in hospitals. It may also identify those who are not infected much earlier allowing them to be taken out of isolation rooms earlier and sent home quickly, easing pressure on the NHS. Previous studies showed that rapidly testing for viruses close to the patient, rather than in laboratories, leads to improvement in patient care. The aim of this study is to find out whether using a new rapid test for COVID-19 performed near the patient leads to earlier decision making and better care for patients.

Who can participate?
Patients aged 18 and over with suspected COVID-19

What does the study involve?
Patients will have a nose and throat swab collected and tested immediately using the new rapid test (QIAstat-Dx Respiratory n-CoV Panel). Results are available in one hour and will be communicated immediately to clinical and infection control teams. There is no patient follow up but clinical outcome data are collected retrospectively from case notes for the duration of hospitalisation, up to 30 days later.

What are the possible benefits and risks of participating?
The potential benefits of the new test are having a rapid result for Covid-19 and other infections which may improve clinical management including the rapid and appropriate use of isolation facilities. Beyond the mild discomfort of having upper respiratory swabs and blood taken, there are not expected to be any significant risks from participating.

Where is the study run from?
Southampton General Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2020 to April 2021

Who is funding the study?
University Hospital Southampton NHS Foundation Trust (UK)

Who is the main contact?
Dr Tristan Clark
t.w.clark@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tristan Clark

ORCID ID

Contact details

LF101
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)2381208410
t.w.clark@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RHM MED1696, IRAS 280621

Study information

Scientific title

Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: a prospective, interventional, non-randomised pre and post implementation study (CoV-19POC)

Acronym

CoV-19POC

Study hypothesis

Routine molecular point-of-care testing for COVID-19 will reduce the time to results and improve the clinical management of patients presenting to hospital with acute respiratory illness, compared to the reference standard of laboratory RT-PCR testing.

Ethics approval

Approved 16/03/2020, South Central - Hampshire A Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8033, hampshirea.rec@hra.nhs.uk), ref: 20/SC/0138

Study design

Prospective interventional non-randomised pre and post implementation study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Patients will have a nose and throat swab collected and tested immediately using the QIAstat-Dx Respiratory n-CoV Panel. Results are available in one hour and will be communicated immediately to clinical and infection control teams. There is no patient follow up but clinical outcome data are collected retrospectively from case notes and hospital information systems for the duration of hospitalisation, up to 30 days post-intervention.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Time from COVID-19 test being requested to the result being available to clinical teams in minutes and hours, recorded during hospitalisation

Secondary outcome measures

Measured using retrospective analysis of case notes and hospital information systems and unless specified otherwise measured for the duration of hospitalisation or up to 30 days, whichever is shorter:
1. The time from presentation to hospital to COVID-19 test result
2. Time from admission to isolation of COVID-19 positive cases
3. Time from admission to de-isolation of COVID-19 negative patients
4. Duration of isolation facility use
5. Duration of negative-pressure isolation facility use
6. Duration of hospitalisation
7. Number and proportion of clinically unsuspected COVID-19 positive patients detected
8. Proportion of patients treated with antibiotics
9. Proportion of patients treated with single doses or brief courses (<48 hours) of antibiotics
10. Duration of antibiotic use, days
11. Proportion of all influenza antiviral use occurring in influenza-positive patients
12. Proportion of all influenza antiviral use occurring in influenza-negative patients
13. Time from admission to influenza antiviral commencement
14. Duration of influenza antiviral use, days and doses
15. Time from admission to isolation of influenza-positive cases, hours
16. Time from admission to de-isolation of influenza negative cases, hours
17. Proportion of patients with ICU or RHDU admission
18. Proportion readmitted to hospital within 30 days
19. In hospital, 30 and 60 day mortality
20. Reliability (proportion of run failures), ease-of-use scores, and implementation feasibility assessment (narrative) of QiAstat-21. Dx Respiratory Panel Plus, used at the point of care
22. Sensitivity, specificity, positive predicted value, negative predictive value, percentage positive agreement, percentage negative agreement, percentage overall agreement, and overall diagnostic accuracy of QIAstat-Dx SARS-CoV-2 assay (as part of QIAstat-Dx Respiratory Panel)

Overall trial start date

07/02/2020

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Is a patient in ED, AMU, HDU, GICU, medical wards, or another location within Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
2. Aged ≥18 years old
3. Can be recruited to the study within 24 hours of presentation to hospital
Plus:
4. Has acute respiratory illness (ARI)*
OR
5. Does not have ARI but is a suspected case of COVID-19 according to the current PHE case definition OR
6. Does not have ARI or fulfil the PHE case definition of a suspected case but testing for SARS-CoV-2 is considered necessary by the responsible clinical team
*An episode of acute respiratory illness is defined as an acute upper or lower respiratory illness (including rhinitis, rhino-sinusitis, pharyngitis, pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of COPD, asthma or bronchiectasis). For the study, acute respiratory illness as a provisional, working, differential or confirmed diagnosis must be made by a treating clinician

Staff testing
Non-hospitalised hospital staff members may be included in the post-implementation phase of the study, if they satisfy the other inclusion and exclusion criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Not fulfilling all the inclusion criteria
2. Declines nasal/pharyngeal swabbing
3. Consent declined or consultee consent declined
4. Already recruited to the study in the last 30 days

Recruitment start date

20/03/2020

Recruitment end date

01/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
University Hospital Southampton NHS Foundation Trust Research and Development (R&D) Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust

Sponsor details

Research and Development (R&D)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2381 203920
sponsor@uhs.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.uhs.nhs.uk/Research/ContactRAndD.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Southampton NHS Foundation Trust

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

No additional study documentation is available at this time although the protocol will be subsequently published. The results will be published in high-impact scientific journals and presented at national and international conferences - dependent on travel restrictions.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Tristan Clark (t.w.clark@soton.ac.uk). Data will be made available in 3 months following publication for a period of 5 years. All of the individual participant data collected during the trial, after de-identification will be made available. It will be available to researchers who provide methodologically sounds proposal to achieve the aims in the approved proposal including individual participant meta-analysis. Proposals should be directed to the above PI. All data will be de-identified. Informed consent will be obtained from all patients. There are no known ethical or legal restrictions currently.

Intention to publish date

01/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/03/2020: Trial's existence confirmed by South Central - Hampshire A Research Ethics Committee.