COVID-19Phase 3VIVALDI-CTNCT05639205
Shaping Care Home COVID-19 Testing Policy
A Phase 3 study testing Lateral Flow Device in people with COVID-19, run by University College, London.
Trial summary
The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Lateral Flow Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Apr 2024
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Only care home staff are eligible to participate in the testing intervention. This includes temporary (agency) staff with no restrictions i.e. catering staff, administrative staff, maintenance staff, in addition to those in a resident-facing role.
- All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation.
- All care home residents at participating home are eligible for data collection and analysis of the outcomes specified.
Who cannot join
- Visitors, residents and relatives are not eligible to take part in the testing intervention.
- Staff who visit the care home to provide care but are not employed by the care home e.g. GPs, health visitors are not eligible to take part in either the interviews or the testing intervention.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Shaping Care Home COVID-19 Testing Policy: A Pragmatic Cluster Randomised Controlled Trial of Asymptomatic Testing Compared to Standard Care in Care Home Staff.
The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes.
The trial aims to quantify the benefits and harms of regular asymptomatic testing in care home staff to inform policy. The rationale for regular asymptomatic testing is that it may reduce the risk of severe disease in residents and the frequency/severity of outbreaks.
Read more
Participants (care home staff) will perform regular asymptomatic tests for Covid-19. Should they test positive they will be required to refrain from working and be provided with sick pay.
Care providers will be reimbursed for the costs of employing agency staff to cover staff sickness absence that results directly from the trial.
Read the detailed description
To date the evidence based underpinning elements of the intervention has been developed through engagement work with the National Care Forum, senior managers of care homes and three stakeholder events with front-line care home staff. It will be finalised through a series of further workshops. These workshops will 1) consolidate existing insights into routine testing gleaned through past experiences in the COVID-19 pandemic; 2) discuss the intervention prototype; 3) operationalise it in ways which are likely to be acceptable and appropriate within the sector.
The testing intervention will comprise of four modules that will be delivered in combination. Module 1: support payments for staff to enable them to self-isolate when unwell. Module 2: Branding and messaging around testing to promote engagement with testing. Module 3: Accessing training, protocols and planning. Module 4: Regular asymptomatic staff testing for COVID-19 using LFDs.
Asymptomatic testing will be in addition to symptomatic testing for staff and residents, which is standard policy for all care homes in England.
Providers will also receive funding to reimburse costs associated with employing agency staff to cover sickness absence for asymptomatic staff who test positive in the trial.
Non-intervention care home residents and staff will be subject to the testing policy that is in place nationally at the time of the trial. Care home staff in control homes will not receive support payments (Module 1) and testing in control homes will not be supported by branding or messaging (Module 2). The degree to which training and testing protocols are already in place in control homes (Module 3) will be investigated in the stakeholder workshops.
- Conditions
- COVID-19
- Being tested
- Lateral Flow Device
- Keywords
- Lateral Flow Device
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Flow DeviceDiagnostic test
Regular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | LFD testing for Covid-19 with sickness support payment. Care providers will receive funding to reimburse the costs of employing agency staff to cover sickness absence in asymptomatic staff who test positive for COVID. Receives: Diagnostic Test: Lateral Flow Device |
| Arm B | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The primary outcome is the incidence of COVID-19 related hospital admissions in residents, defined as admissions with a relevant ICD-10 codes (COVID hospitalisations to be defined as any hospital admission record with a primary or secondary ICD10 code of 'U071') and/or admissions in residents who test positive for COVID-19 within 24h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers.
Measured: 4 months
Secondary outcomes (11)
Incidence rate of hospital admissions
Incidence rate of hospital admissions (all-cause) in residents for non-elective care, measured as events per 100,000 person-days of follow-up over the duration of the trial
Measured: 4 months
Incidence rate of COVID-associated mortality in residents
Incidence rate of COVID-associated mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial.
COVID-associated mortality will be defined as death within 28 days of a positive SARS-CoV-2 test and/or COVID-19 recorded as primary or secondary cause of death on the death certificate (using ICD-10 coding).
Measured: 4 months
Incidence of all-cause mortality in residents
Incidence of all-cause mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial
Measured: 4 months
Testing uptake in staff
Testing uptake in staff, measured as proportion of staff at each home participating in testing during each week of the trial
Measured: Once per week for 4 months
Prevalence of SARS-CoV-2 among staff who test
Prevalence of SARS-CoV-2 among staff who test, measured as proportion of staff with positive test result among those with at least one test recorded during each week of the trial
Measured: Once per week for 4 months
Incidence rate of SARS-CoV-2 infections detected in residents
Incidence rate of SARS-CoV-2 infections detected in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial
Measured: 4 months
Incidence rate of home-level outbreaks
Incidence rate of home-level outbreaks, measured as events per 1000 days of follow-up over the duration of the trial
Measured: 4 months
Duration of outbreaks
Duration of outbreaks, measured as days from first to last case within outbreaks occurring within the trial period
Measured: 4 months
Incidence rate of care home closures due to outbreaks
Incidence rate of care home closures due to outbreaks, measured as events per 1000 days of follow-up over the duration of the trial
Measured: 4 months
Staff sick
Proportion of staff per home who are off sick at each home during each week of the trial
Measured: Once per week for 4 months
Agency staff filled shifts
Proportion of all shifts filled by agency staff at each home during each week of the trial
Measured: Once per week for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Shallcross, Professor, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639205
- Sponsor's protocol ID
- CTU/2022/405
- Acronym
- VIVALDI-CT
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data-sharing plans for the current study are still to be confirmed and will be made available at a later date.
Publications
Stirrup O, Blackstone J, Cullen-Stephenson I, Fenner R, Adams N, Leiser R, Krutikov M, Azmi B, Freemantle N, Gordon A, Regan M, Knapp M, Gosce L, Henderson C, Hopkins S, Verma A, Cassell J, Cadar D, Fowler T, Copas A, Flowers P, Shallcross L. VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff. PLoS One. 2025 Jul 2;20(7):e0324908. doi: 10.1371/journal.pone.0324908. eCollection 2025.
PubMed 40601586
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaping Care Home COVID-19 Testing Policy: A Pragmatic Cluster Randomised Controlled Trial of Asymptomatic Testing Compared to Standard Care in Care Home Staff.
- ClinicalTrials.gov ID
- NCT05639205
- Acronym / sponsor ID
- VIVALDI-CT / CTU/2022/405
- Conditions
- COVID-19
- Keywords
- Lateral Flow Device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 Dec 2022 (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.
The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes.
The trial aims to quantify the benefits and harms of regular asymptomatic testing in care home staff to inform policy. The rationale for regular asymptomatic testing is that it may reduce the risk of severe disease in residents and the frequency/severity of outbreaks.
Participants (care home staff) will perform regular asymptomatic tests for Covid-19. Should they test positive they will be required to refrain from working and be provided with sick pay.
Care providers will be reimbursed for the costs of employing agency staff to cover staff sickness absence that results directly from the trial.
Detailed description
To date the evidence based underpinning elements of the intervention has been developed through engagement work with the National Care Forum, senior managers of care homes and three stakeholder events with front-line care home staff. It will be finalised through a series of further workshops. These workshops will 1) consolidate existing insights into routine testing gleaned through past experiences in the COVID-19 pandemic; 2) discuss the intervention prototype; 3) operationalise it in ways which are likely to be acceptable and appropriate within the sector.
The testing intervention will comprise of four modules that will be delivered in combination. Module 1: support payments for staff to enable them to self-isolate when unwell. Module 2: Branding and messaging around testing to promote engagement with testing. Module 3: Accessing training, protocols and planning. Module 4: Regular asymptomatic staff testing for COVID-19 using LFDs.
Asymptomatic testing will be in addition to symptomatic testing for staff and residents, which is standard policy for all care homes in England.
Providers will also receive funding to reimburse costs associated with employing agency staff to cover sickness absence for asymptomatic staff who test positive in the trial.
Non-intervention care home residents and staff will be subject to the testing policy that is in place nationally at the time of the trial. Care home staff in control homes will not receive support payments (Module 1) and testing in control homes will not be supported by branding or messaging (Module 2). The degree to which training and testing protocols are already in place in control homes (Module 3) will be investigated in the stakeholder workshops.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Diagnostic Test: Lateral Flow DeviceLFD testing for Covid-19 with sickness support payment. Care providers will receive funding to reimburse the costs of employing agency staff to cover sickness absence in asymptomatic staff who test positive for COVID. |
| Arm B | No intervention | –Usual Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Only care home staff are eligible to participate in the testing intervention. This includes temporary (agency) staff with no restrictions i.e. catering staff, administrative staff, maintenance staff, in addition to those in a resident-facing role.
- All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation.
- All care home residents at participating home are eligible for data collection and analysis of the outcomes specified.
Key exclusion criteria (2 listed)
- Visitors, residents and relatives are not eligible to take part in the testing intervention.
- Staff who visit the care home to provide care but are not employed by the care home e.g. GPs, health visitors are not eligible to take part in either the interviews or the testing intervention.
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 |
|---|---|---|
| Lateral Flow DeviceRegular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell. | Diagnostic test | Arm A |
Primary outcome
Primary Outcome
Time frame: 4 months
The primary outcome is the incidence of COVID-19 related hospital admissions in residents, defined as admissions with a relevant ICD-10 codes (COVID hospitalisations to be defined as any hospital admission record with a primary or secondary ICD10 code of 'U071') and/or admissions in residents who test positive for COVID-19 within 24h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers.
11 secondary outcomes
Incidence rate of hospital admissions
Time frame: 4 months
Incidence rate of COVID-associated mortality in residents
Time frame: 4 months
Incidence of all-cause mortality in residents
Time frame: 4 months
Testing uptake in staff
Time frame: Once per week for 4 months
Prevalence of SARS-CoV-2 among staff who test
Time frame: Once per week for 4 months
Incidence rate of SARS-CoV-2 infections detected in residents
Time frame: 4 months
Incidence rate of home-level outbreaks
Time frame: 4 months
Duration of outbreaks
Time frame: 4 months
Incidence rate of care home closures due to outbreaks
Time frame: 4 months
Staff sick
Time frame: Once per week for 4 months
Agency staff filled shifts
Time frame: Once per week for 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Derived from this study: PubMed 40601586Stirrup O, Blackstone J, Cullen-Stephenson I, Fenner R, Adams N, Leiser R, Krutikov M, Azmi B, Freemantle N, Gordon A, Regan M, Knapp M, Gosce L, Henderson C, Hopkins S, Verma A, Cassell J, Cadar D, Fowler T, Copas A, Flowers P, Shallcross L. VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff. PLoS One. 2025 Jul 2;20(7):e0324908. doi: 10.1371/journal.pone.0324908. eCollection 2025.
- Individual participant dataSharing planned: Undecided. The data-sharing plans for the current study are still to be confirmed and will be made available at a later date.
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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.
Laura Shallcross, Professor principal investigator
UCL
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lateral Flow Device in people with COVID-19, run by University College, London.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Shallcross, Professor (0203 549 5540, l.shallcross@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639205, which also lists 1 linked publication.
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 9 Dec 2022.