Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
461 participants
INTERVENTIONAL
2020-07-02
2020-10-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard of care
Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14
Nasopharyngeal swab and main laboratory
Standard of care testing
Near Patient Testing
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
Q16 testing
Nasal swab tested on a rapid near patient device
Interventions
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Q16 testing
Nasal swab tested on a rapid near patient device
Nasopharyngeal swab and main laboratory
Standard of care testing
Eligibility Criteria
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Inclusion Criteria
* Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.
Exclusion Criteria
* 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.
18 Years
130 Years
ALL
Yes
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Joanne Martin
Role: STUDY_CHAIR
Queen Mary University London
Locations
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Queen Mary University London
London, , United Kingdom
Countries
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References
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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.
Kimball 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.
Roxby 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.
World 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.
Sheridan 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.
Department 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.
Foundation 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.
NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.
Other Identifiers
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285524
Identifier Type: -
Identifier Source: org_study_id
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