Does point-of-care testing for coronavirus in hospital improve patient care compared to laboratory testing?
| ISRCTN | ISRCTN14966673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14966673 |
| IRAS number | 280621 |
| Secondary identifying numbers | RHM MED1696, IRAS 280621 |
- Submission date
- 17/03/2020
- Registration date
- 18/03/2020
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 1 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
Contact information
Scientific
LF101
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381208410 |
|---|---|
| t.w.clark@soton.ac.uk |
Study information
| Study design | Prospective interventional non-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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, controlled study (CoV-19POC) |
| Study 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(s) | Approved 16/03/2020, Substantial Amendment 1 approved 23/06/2020, 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 |
| 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 1 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. Added 21/07/2020: Participant allocation: during periods when point-of-care testing was operational, potential patient-participants were approached for recruitment into the intervention; patients tested in the same time period by the local laboratory by RT-PCR were assessed for eligibility for entering the control group. |
| Intervention type | Other |
| 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 | Current secondary outcome measures as of 20/07/2020: 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 spent in COVID-19 assessment cohort area 3. Time to definitive ward move 4. Number of bed moves 5. Duration of hospitalisation 6. Number and proportion of clinically unsuspected COVID-19 positive patients detected 7. Proportion of patients treated with antibiotics 8. Proportion of patients treated with single doses or brief courses (<48 hours) of antibiotics 9. Duration of antibiotic use, days 10. Proportion of all influenza antiviral use occurring in influenza-positive patients 11. Proportion of all influenza antiviral use occurring in influenza-negative patients 12. Time from admission to influenza antiviral commencement 13. Duration of influenza antiviral use, days and doses 14. Proportion of patients with ICU or RHDU admission 15. Proportion readmitted to hospital within 30 days 16. In-hospital, 30- and 60-day mortality 17. Reliability (proportion of run failures), ease-of-use scores, and implementation feasibility assessment (narrative) of QIAstat-Dx Respiratory SARS-CoV-2 Panel, used at the point-of-care 18. 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 SARS-CoV-2 Panel) compared to laboratory PCR using the PHE RdRP assay Previous 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 study start date | 07/02/2020 |
| Overall study end date | 01/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 1055 |
| 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 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 | 29/04/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Research and Development (R&D)
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development (R&D)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)2381 203920 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | https://www.uhs.nhs.uk/Research/ContactRAndD.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2020 | 13/10/2020 | Yes | No |
| Results article | SARS-CoV-2 Viral load at presentation to hospital is independently associated with the risk of death | 04/08/2021 | 09/08/2021 | Yes | No |
| Results article | Combined RT-PCR and Host Response Point-of-Care Testing in Patients Hospitalised with Suspected COVID-19: A Prospective Diagnostic Accuracy Study | 09/05/2022 | 10/05/2022 | Yes | No |
| Protocol (other) | 08/04/2020 | 10/10/2022 | No | No | |
| Protocol file | version 2.0 | 03/06/2020 | 10/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Comparison of patients with and without SARS-CoV-2 infection | 28/09/2020 | 08/04/2024 | Yes | No |
| Results article | 21/06/2020 | 08/04/2024 | Yes | No |
Additional files
Editorial Notes
08/04/2024: Publication references added.
10/10/2022: Protocol file uploaded.
10/05/2022: Publication reference added.
09/08/2021: Publication reference added.
13/10/2020: Publication reference added.
21/07/2020: The interventions were updated and the total final enrolment number was added.
20/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2021 to 29/04/2020.
2. The scientific title was changed from '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)' to 'Evaluating the clinical impact of routine molecular point-of-care testing for COVID-19 in adults presenting to hospital: a prospective, interventional, non-randomised, controlled study (CoV-19POC)'.
3. Ethics approval and secondary outcome measures updated.
4. The study design was changed from 'Prospective interventional non-randomised pre and post implementation study' to 'Prospective interventional non-randomised controlled study'.
5. The target number of participants was changed from '500' to '500 participants in the intervention group and circa 500 in the control group.'
18/03/2020: Trial's existence confirmed by South Central - Hampshire A Research Ethics Committee.
