Covid-SMART: Optimising lateral flow testing for NHS staff release from quarantine and return from isolation
| ISRCTN | ISRCTN47058442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47058442 |
| IRAS number | 311842 |
| Secondary identifying numbers | UoL001685, IRAS 311842 |
- Submission date
- 25/01/2022
- Registration date
- 26/01/2022
- Last edited
- 20/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The problem addressed by this research is the lack of evidence for policymakers on how to balance the risks from Covid-19 directly with the indirect risks posed by key worker staff being absent after close contact with Covid-19 cases, or after having just recovered from infection with the virus - particularly with the Omicron variant. Recent NHS staff testing policies try to balance these risks, however, there is a need to know whether nose-only swabbing is sufficient for daily testing of contacts to release them back to work from quarantine. There is also a need to know whether 2 consecutive days of negative lateral flow tests from day 5 after exposure is sufficient to allow staff to return from work after they have recovered from infection. The potential additional risk mitigation of using two types of lateral flow tests is also understudied. In addition, there is a need to understand whether people who still test positive with lateral flow tests at day 10 after exposure can still be infectious.
The aim of this research is to maximise patient safety by balancing the risks from Covid-19 directly with those posed by key worker absence due to Covid-19.
Who can participate?
Any NHS staff using the Covid-19 staff testing facilities for contacts or cases at Liverpool University Hospitals NHS Foundation Trust can participate. All participants must be fully vaccinated.
What does the study involve?
Participants will be required to perform self-tests for COVID-19 for up to 10 days.
What are the potential benefits and risks of participating?
Participants will have additional Covid-safety assurance that they are likely to reduce the risk of transmitting the Covid virus to their patients and colleagues by taking part in this study with additional testing. Some may also perceive a benefit of contributing to policy-relevant evidence that is urgently needed. There are no known risks from participation, beyond the inconvenience of taking extra tests.
When is the study starting and how long is it expected to run for?
January 2022 to March 2022
Who is funding the study?
The UK Health Security Agency.
Who is the main contact?
Professor Iain Buchan, buchan@liverpool.ac.uk
Contact information
Principal Investigator
Institute of Population Health
University of Liverpool
F206, Waterhouse Building
1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom
 ORCID ID |
0000-0003-3392-1650 |
|---|---|
| Phone | +44 7802853367 |
| buchan@liverpool.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Workplace |
| Study type | Diagnostic |
| Study type | Participant information sheet |
| Scientific title | Covid-SMART release & return: urgent study of dynamic quarantine and isolation with alternative lateral flow devices and regimens |
| Study acronym | Covid-SMART Release & Return |
| Study hypothesis | Research questions addressed by the study: 1. Does the addition of dual swabbing and use of two different manufacturer’s devices at the same time add substantial value (in timely case detection) over a single device? 2. Does nose only swabbing detect Omicron infection as early as nose plus throat swabbing for lateral flow test (LFT)? 3. Is two consecutive days of negative (dual) LFT results a reliable indicator that an Omicron case will not subsequently revert to (validated) LFT positive/shedding within the same course of infection? 4. Will NHS staff cases take up the offer of an accelerated return to work given serial negative LFTs when their employer strongly encourages/organises participation? |
| Ethics approval(s) | Liverpool Central University Research Ethics Committee, ref: 11002 |
| Condition | Covid-19. Urgent study of dynamic quarantine and isolation with alternative lateral flow devices and regimens for NHS staff |
| Intervention | Urgent pilot service evaluation with randomised order of swabbing - nose/throat using Innova Lateral Flow Device (LFD) and nose only using Orient Gene LFD and internally controlled comparison of single vs dual Lateral Flow Test (LFT) results. Observational study of serial dual LFT vs PCR Ct. Quantitative and qualitative (participant and employer survey) observational study of uptake and staffing impacts. In concert with NERVTAG Virology Cell, a sample of Day 5 PCR swabs will be sent for viral culture. Uninfected contact participant pathway: 1. Household member of NHS worker is notified they are Covid positive, so their NHS contact starts quarantine and notifies their employer. 2. Employer has adopted SMART Release & Return testing schedule as their local standard policy and directs the staff member to a booking website for the scheme, which provides and information sheet, consent process and directions to the unit/site. 3. Participant receives a 10-day pack of daily dual LFT + 2 PCR home test kits, and if they have not had a positive Covid test in the past 90 days they take a swab for quick turnaround (binary) PCR. 4. Participant receives PCR negative result on Day 0 and returns to work on Day 1 with DCT. 5. Innova (nose/throat) and either Orient Gene (nose only) lateral flow devices are used each morning (or pre-shift) before breakfast in randomised order for 10 days – an information sheet in the pack directs the participant day by day. Either LFD turning positive is an overall positive result. 6. On day 1 the participant also takes a home PCR swab (randomised order with the two LFTs) and returns it by post to Pillar 2 / other (ringfenced) Q-RT-PCR capacity, and the result is not used for any purpose other than research. 7. A second Q-RT-PCR swab is taken on day 5. 8. Exit questionnaire gathers participant experiences. Asymptomatic infected contact participant pathway: 1. Household member of NHS worker is notified they are Covid positive, so their NHS contact starts quarantine and notifies their employer. 2. Employer has adopted SMART Release & Return testing schedule as their local standard policy and directs the staff member to a booking website for the scheme, and directs them to the standard testing/reception site. 3. Consented participant takes quick turnaround (binary) PCR test to return to work from quarantine on DCT and receives a 10-day pack of daily dual LFT + 2 PCR home test kits. 4. Participant receives PCR positive result on Day 0 and stays at home. 5. Innova (nose/throat) and Orient Gene (nose only) lateral flow devices are used each morning before breakfast in randomised order – an information sheet in the pack directs the participant day-by-day. 6. On day 1 the participant also takes a home PCR swab (randomised order with the two LFTs) and returns it by post to Pillar 2 / other (ringfenced) Q-RT-PCR capacity, and the result is not used for any purpose other than research. 7. Second Q-RT-PCR swab is taken on day 5. (Participant is selected to be in the viral culture sample of 30 cases – and their swab in viral transport medium is collected from their home). 8. If day 5 and 6 dual LFT results (4 tests) are negative the participant may return to work. 9. Daily dual LFT testing continues until day 10. 10. If still testing LFT positive at day 10 the participant is advised to call and arrange a RT-Q-PCR swab in viral transport medium for culture. 11. Exit questionnaire gathering participant experiences. New case referred to the study 1. NHS worker is notified they are Covid positive and notifies their employer. 2. Employer has adopted SMART Release & Return testing schedule as their local standard policy and directs the staff member to a booking website for the scheme, and directs them to the standard testing/reception site. 3. Consented participant receives a 10-day pack of daily dual LFT + 2 PCR home test kits. 4. Innova (nose/throat) and Orient Gene (nose only) lateral flow devices are used each morning before breakfast in randomised order – an information sheet in the pack directs the participant day-by-day. 5. On day 1 the participant also takes a home PCR swab (randomised order with the two LFTs) and returns it by post to Pillar 2 / other (ringfenced) Q-RT-PCR capacity, and the result is not used for any purpose other than research. 6. Second Q-RT-PCR swab is taken on day 5. 7. If day 5 and 6 dual LFT results (4 tests) are negative the participant may return to work. 8. Daily dual LFT testing continues until day 10. 9. If still testing LFT positive at day 10 the participant is advised to call and arrange a RT-Q-PCR swab in viral transport medium for culture. 10. Exit questionnaire gathering participant experiences. |
| Intervention type | Other |
| Primary outcome measure | Covid case detection measured by dual swabbing of two different manufacturers lateral flow devices at the same time daily for up to 10 days |
| Secondary outcome measures | The earliest day of detection of Omicron infection measured using nose only swabbing lateral flow device Orient Gene |
| Overall study start date | 04/01/2022 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 2,000 |
| Total final enrolment | 1176 |
| Participant inclusion criteria | NHS staff working at Liverpool University Hospital Foundation Trust (LUHFT) sites who are fully vaccinated |
| Participant exclusion criteria | LUHFT staff that are not fully vaccinated |
| Recruitment start date | 31/01/2022 |
| Recruitment end date | 11/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
University/education
Clinical Directorate
4th Floor Thompson Yates Building
Faculty of Health and Life Sciences
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 7717863747 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liverpool.ac.uk |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Health & Social Care, DH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 24/04/2023: Planned publication in high impact peer-reviewed journal following timely reporting to the UK Health Security Agency Testing Initiatives Evaluation Board Previous publication and dissemination plan: Planned publication in high impact peer-reviewed journal |
| IPD sharing plan | Current IPD sharing plan as of 21/05/2024: The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (GitHub): https://github.com/iain-buchan/cipha/blob/master/SMART_RR_Anonymised_Data.zip The type of data stored: Anonymised, individual-level participant data on lateral flow test results Dates of availability: Anytime Whether consent from participants was required and obtained: Yes Comments on data anonymization: Fully anonymised – no feasible deductive disclosure Previous IPD sharing plan: The datasets generated during and analysed during the current study will be stored in a non-publically available repository: https://www.cipha.nhs.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.9 | 24/01/2022 | 26/01/2022 | No | No |
| Funder report results | 05/09/2022 | 24/04/2023 | No | No | |
| Protocol file | version 4.7 | 26/07/2022 | 24/04/2023 | No | No |
| Statistical Analysis Plan | version 4.7 | 26/07/2022 | 24/04/2023 | No | No |
| Dataset | 20/05/2024 | 21/05/2024 | No | No | |
| Participant information sheet | 30/12/2023 | 21/05/2024 | No | Yes | |
| Results article | 11/11/2024 | 20/11/2024 | Yes | No |
Additional files
Editorial Notes
20/11/2024: Publication reference added.
21/05/2024: Dataset and participant information sheet added. IPD sharing plan updated.
24/04/2023: The following changes were made to the trial record:
1. Ethics approval details and total final enrolment added.
2. The publication and dissemination plan was updated.
3. Funder report, protocol and statistical analysis plan uploaded.
26/01/2022: Trial's existence confirmed by UK Health Security Agency.
