CICERO- A Care Home Study of COVID-19

July 31, 2023 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2ES
        • Queen Mary University London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CoV-2 Infection after 21 days
Time Frame: 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
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CoV-2 Infection after 14 days
Time Frame: 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.
14 days
Cases of suspected or confirmed CoV-2 infection
Time Frame: 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.
14 days
Hospitalisation and death
Time Frame: 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.
21 days and 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Study Chair: Joanne Martin, Queen Mary University London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Actual)

October 27, 2020

Study Completion (Actual)

October 27, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 285524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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