CICERO- A Care Home Study of COVID-19
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|ClinicalTrials.gov Identifier: NCT04453553|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID||Diagnostic Test: Q16 testing Diagnostic Test: Nasopharyngeal swab and main laboratory||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomised cluster trial of care homes|
|Masking:||None (Open Label)|
|Masking Description:||No masking will be used as the study arms have different testing patterns|
|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|
|Estimated Study Start Date :||July 2, 2020|
|Estimated Primary Completion Date :||August 28, 2020|
|Estimated Study Completion Date :||September 28, 2020|
Active Comparator: Standard of care
Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14
Diagnostic Test: Nasopharyngeal swab and main laboratory
Standard of care testing
Experimental: 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
Diagnostic Test: Q16 testing
Nasal swab tested on a rapid near patient device
- 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
- CoV-2 Infection after 14 days [ Time Frame: 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.
- Cases of suspected or confirmed CoV-2 infection [ Time Frame: 14 days ]The cumulative number of suspected or confirmed cases of CoV-2 infection after 14 days, within the care home residents, staff and visitors.
- Hospitalisation and death [ Time Frame: 21 days and 40 days ]The cumulative number of confirmed COVID-19-related hospitalisations and deaths of care home residents, staff and visitors after 21 and 40 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453553
|Contact: Joanne Martin||07713744054||J.email@example.com|
|Queen Mary University London|
|London, United Kingdom, E1 2ES|
|Study Chair:||Joanne Martin||Queen Mary University London|