CICERO- A Care Home Study of COVID-19

Sponsor

Queen Mary University of London (Other)

Overall Status

Unknown status

CT.gov ID

NCT04453553

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Diagnostic Test: Q16 testing Diagnostic Test: Nasopharyngeal swab and main laboratory	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomised cluster trial of care homesrandomised cluster trial of care homes

Masking:

None (Open Label)

Masking Description:

No masking will be used as the study arms have different testing patterns

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Jul 2, 2020

Anticipated Primary Completion Date :

Aug 28, 2020

Anticipated Study Completion Date :

Sep 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14	Diagnostic Test: Nasopharyngeal swab and main laboratory Standard of care testing
Experimental: Near Patient 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	Diagnostic Test: Q16 testing Nasal swab tested on a rapid near patient device

Arm

Intervention/Treatment

Active Comparator: Standard of care

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

Diagnostic Test: Nasopharyngeal swab and main laboratory

Standard of care testing

Experimental: Near Patient 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

Diagnostic Test: Q16 testing

Nasal swab tested on a rapid near patient device

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary University London	London		United Kingdom	E1 2ES

Sponsors and Collaborators

Queen Mary University of London

Investigators

Study Chair: Joanne Martin, Queen Mary University London

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Queen Mary University of London

ClinicalTrials.gov Identifier:

NCT04453553

Other Study ID Numbers:

285524

First Posted:

Jul 1, 2020

Last Update Posted:

Jul 1, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Queen Mary University of London

COVID-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 1, 2020