CICERO- A Care Home Study of COVID-19

Queen Mary University of London

Status: Terminated

Conditions: COVID

Treatments: Diagnostic Test: Q16 testing; Diagnostic Test: Nasopharyngeal swab and main laboratory

Study type: Interventional

Funder types: Other

Identifiers

NCT04453553

285524

Details and patient eligibility

About

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.

Full 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)

Enrollment: 461 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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461 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14

Treatment:

Diagnostic Test: Nasopharyngeal swab and main laboratory

Near Patient Testing

Experimental group

Description:

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

Treatment:

Diagnostic Test: Q16 testing