CICERO- A Care Home Study of COVID-19

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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COVID

Intervention / Treatment
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* Diagnostic Test: Q16 testing
* Diagnostic Test: Nasopharyngeal swab and main laboratory


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised cluster trial of care homes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14 | Diagnostic Test: Nasopharyngeal swab and main laboratory<br>* Standard of care testing<br>|
| Experimental: Near Patient Testing<br>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 | Diagnostic Test: Q16 testing<br>* Nasal swab tested on a rapid near patient device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19