CICERO- A Care Home Study of COVID-19

COVID Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04453553
• Other study ID #: 285524
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: October 27, 2020

Study information

• Verified date: July 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 461
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

Diagnostic Test:
• Q16 testing
Nasal swab tested on a rapid near patient device
• Nasopharyngeal swab and main laboratory
Standard of care testing

Locations

Country	Name	City	State
United Kingdom	Queen Mary University London	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020

Department of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020

Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results

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. Erratum In: Nat Med. 2020 Sep;26(9):1491-1493. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Euro Surveill. 2020 Jun;25(22): — View Citation

NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.

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)

Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020

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. — View Citation

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. — View Citation

University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19

World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	21 days
Secondary	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.	14 days
Secondary	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.	14 days
Secondary	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.	21 days and 40 days