NCT04453553

CICERO- A Care Home Study of COVID-19

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Accepted

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)

Conditions

• COVID

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Q16 testing	Nasal swab tested on a rapid near patient device
DIAGNOSTIC_TEST	Nasopharyngeal swab and main laboratory	Standard of care testing

Timeline

• Start date: 2020-07-02
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2020-07-01
• Last updated: 2023-08-02

Locations

1 site across 1 country: United Kingdom