CICERO- A Care Home Study of COVID-19

Not Applicable

Terminated

• Conditions: COVID
• Interventions: Diagnostic Test: Q16 testing; Diagnostic Test: Nasopharyngeal swab and main laboratory

• Registration Number: NCT04453553
• Lead Sponsor: Queen Mary University of London

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)

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2020-07-02
• Primary Completion: 2020-10-27
• Study Completion: 2020-10-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 461

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near Patient Testing	Q16 testing	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
Standard of care	Nasopharyngeal swab and main laboratory	Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Queen Mary University London; 🇬🇧 London, United Kingdom