Clinical trial NCT04453553: CICERO- A Care Home Study of COVID-19
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID
Keywords: COVID-19
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised cluster trial of care homes
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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.

Primary outcomes:
measure: CoV-2 Infection after 21 days
timeFrame: 21 days
Secondary outcomes:
measure: CoV-2 Infection after 14 days
timeFrame: 14 days
measure: Cases of suspected or confirmed CoV-2 infection
timeFrame: 14 days
measure: Hospitalisation and death
timeFrame: 21 days and 40 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University London
Study officials:
affiliation: Queen Mary University London
name: Joanne Martin
role: STUDY_CHAIR
References:
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