COVID
Conditions
Keywords
COVID-19
Brief 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.
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)
Interventions
DIAGNOSTIC_TESTQ16 testing
Nasal swab tested on a rapid near patient device
DIAGNOSTIC_TESTNasopharyngeal swab and main laboratory
Standard of care testing
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking will be used as the study arms have different testing patterns
Intervention model description
randomised cluster trial of care homes
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CoV-2 Infection after 21 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CoV-2 Infection after 14 days | 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 | 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 | 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. |
Countries
United Kingdom
Outcome results
None listed