COVIDNCT04453553
CICERO- A Care Home Study of COVID-19
A study testing Q16 testing and Nasopharyngeal swab and main laboratory in people with COVID, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents. Read more about this study
- Who is it for?
- Ages 18 to 130 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- Q16 testing and Nasopharyngeal swab and main laboratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2020to 27 Oct 2020
- Phase
- Interventional
- 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 18 to 130 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons resident or requiring access to the care home
- Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.
Who cannot join
- Persons not providing informed consent or withdrawing consent at any time during the study.
- Persons requiring urgent and immediate access to the care home, for example medical staff attending emergency visits.
- Persons unable to provide nasal or oropharyngeal swabs for medical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 in Vitro Diagnostic Near-patient Testing in Care Environments Using a Cluster Randomised Open-label Trial Design in an East London Care Home Population
The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents.
Read the detailed description
Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine testing of residents, and of staff and visitors prior to entering the care home.
Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may detect infected residents and visitors before clinical symptoms are apparent. Earlier detection may lead to earlier implementation of the UK standard of care protocol for Infection prevention and control measures, thereby preventing the asymptomatic infected individuals from introducing and/or transmitting CoV-2 within the care home. This should reduce the transmission by:
Preventing the introduction of the virus into care homes from external visitors e.g., GPs (Inward transmission) Preventing the spread of the virus within care homes and preventing cluster development (internal transmission) Preventing the outward spread of the virus from within care homes by infection of external visitors (Outward transmission)
- Conditions
- COVID
- Being tested
- Q16 testing, Nasopharyngeal swab and main laboratory
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q16 testingDiagnostic test
Nasal swab tested on a rapid near patient device
Nasopharyngeal swab and main laboratoryDiagnostic test
Standard of care testing
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14 Receives: Diagnostic Test: Nasopharyngeal swab and main laboratory |
| Near Patient Testing | Experimental | Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14, with the addition of daily nasal swabs tested via rapid test system Receives: Diagnostic Test: Q16 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
CoV-2 Infection after 21 days
The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors
Measured: 21 days
Secondary outcomes (3)
CoV-2 Infection after 14 days
The cumulative number of confirmed cases of CoV-2 infection after 14 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors.
Measured: 14 days
Cases of suspected or confirmed CoV-2 infection
The cumulative number of suspected or confirmed cases of CoV-2 infection after 14 days, within the care home residents, staff and visitors.
Measured: 14 days
Hospitalisation and death
The cumulative number of confirmed COVID-19-related hospitalisations and deaths of care home residents, staff and visitors after 21 and 40 days.
Measured: 21 days and 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start2 Jul 2020
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Why it stopped: Change in government policy on testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Queen Mary University of 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised cluster trial of care homes
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Martin, Study chair, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453553
- Sponsor's protocol ID
- 285524
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020
University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19
Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020
McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.
PubMed 32220208Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.
PubMed 32240128Roxby AC, Greninger AL, Hatfield KM, Lynch JB, Dellit TH, James A, Taylor J, Page LC, Kimball A, Arons M, Schieve LA, Munanga A, Stone N, Jernigan JA, Reddy SC, Lewis J, Cohen SA, Jerome KR, Duchin JS, Neme S. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):416-418. doi: 10.15585/mmwr.mm6914e2.
PubMed 32271726World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020
Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
PubMed 32183930Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol. 2020 May;38(5):515-518. doi: 10.1038/d41587-020-00010-2. No abstract available.
PubMed 32203294Department of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020
He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.
PubMed 32296168Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results
Primerdesign™ Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. Instructions for Use. Issue 1.01. 20th March 2020. Available at: https://www.fda.gov/media/136309/download (page 21)
Ip DKM, Lau LLH, Chan KH, Fang VJ, Leung GM, Peiris MJS, Cowling BJ. The Dynamic Relationship Between Clinical Symptomatology and Viral Shedding in Naturally Acquired Seasonal and Pandemic Influenza Virus Infections. Clin Infect Dis. 2016 Feb 15;62(4):431-437. doi: 10.1093/cid/civ909. Epub 2015 Oct 30.
PubMed 26518469NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Vitro Diagnostic Near-patient Testing in Care Environments Using a Cluster Randomised Open-label Trial Design in an East London Care Home Population
- ClinicalTrials.gov ID
- NCT04453553
- Acronym / sponsor ID
- 285524
- Conditions
- COVID
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in government policy on testing
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 1 Jul 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.
The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents.
Detailed description
Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine testing of residents, and of staff and visitors prior to entering the care home.
Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may detect infected residents and visitors before clinical symptoms are apparent. Earlier detection may lead to earlier implementation of the UK standard of care protocol for Infection prevention and control measures, thereby preventing the asymptomatic infected individuals from introducing and/or transmitting CoV-2 within the care home. This should reduce the transmission by:
Preventing the introduction of the virus into care homes from external visitors e.g., GPs (Inward transmission) Preventing the spread of the virus within care homes and preventing cluster development (internal transmission) Preventing the outward spread of the virus from within care homes by infection of external visitors (Outward transmission)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised cluster trial of care homes
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Diagnostic Test: Nasopharyngeal swab and main laboratoryScreening for COVID-19 via nasopharyngeal swab taken at day 0 and 14 |
| Near Patient Testing | Experimental | Diagnostic Test: Q16 testingScreening for COVID-19 via nasopharyngeal swab taken at day 0 and 14, with the addition of daily nasal swabs tested via rapid test system |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons resident or requiring access to the care home
- Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.
Key exclusion criteria (3 listed)
- Persons not providing informed consent or withdrawing consent at any time during the study.
- Persons requiring urgent and immediate access to the care home, for example medical staff attending emergency visits.
- Persons unable to provide nasal or oropharyngeal swabs for medical reasons.
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 |
|---|---|---|
| Q16 testingNasal swab tested on a rapid near patient device | Diagnostic test | Near Patient Testing |
| Nasopharyngeal swab and main laboratoryStandard of care testing | Diagnostic test | Standard of care |
Primary outcome
CoV-2 Infection after 21 days
Time frame: 21 days
The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors
3 secondary outcomes
CoV-2 Infection after 14 days
Time frame: 14 days
Cases of suspected or confirmed CoV-2 infection
Time frame: 14 days
Hospitalisation and death
Time frame: 21 days and 40 days
Results and safety
The study was stopped early (reason given: Change in government policy on testing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- BackgroundPublic Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020
- BackgroundUniversity of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19
- BackgroundComas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020
- Background: PubMed 32220208McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.
- Background: PubMed 32240128Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.
- Background: PubMed 32271726Roxby AC, Greninger AL, Hatfield KM, Lynch JB, Dellit TH, James A, Taylor J, Page LC, Kimball A, Arons M, Schieve LA, Munanga A, Stone N, Jernigan JA, Reddy SC, Lewis J, Cohen SA, Jerome KR, Duchin JS, Neme S. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):416-418. doi: 10.15585/mmwr.mm6914e2.
- BackgroundWorld Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020
- Background: PubMed 32183930Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
- Background: PubMed 32203294Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol. 2020 May;38(5):515-518. doi: 10.1038/d41587-020-00010-2. No abstract available.
- BackgroundDepartment of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020
- Background: PubMed 32296168He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.
- BackgroundFoundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results
- Individual participant dataSharing planned: No
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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.
Joanne Martin study chair
Queen Mary University London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q16 testing and Nasopharyngeal swab and main laboratory in people with COVID, run by Queen Mary University of London 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 3 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: stopped early, as of the sponsor's last update on 2 Aug 2023. 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 was stopped early (reason given: Change in government policy on testing). Results are not available in the source record.
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?
CoV-2 Infection after 21 days (time frame: 21 days). 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 NCT04453553, which also lists 15 linked publications.
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 2 Aug 2023.