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
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)

Unknown status
COVID

Diagnostic Test: Q16 testing

Nasal swab tested on a rapid near patient device

Diagnostic Test: Nasopharyngeal swab and main laboratory

Standard of care testing

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 130 Years
Countries
United Kingdom
Locations

Queen Mary University London
London, United Kingdom

Contacts

Joanne Martin
07713744054
J.e.martin@qmul.ac.uk

Joanne Martin, Study Chair
Queen Mary University London

Queen Mary University of London
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19