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CICERO- A Care Home Study of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453553
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID Diagnostic Test: Q16 testing Diagnostic Test: Nasopharyngeal swab and main laboratory Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised 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
Estimated Study Start Date : July 2, 2020
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : September 28, 2020

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453553


Contacts
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Contact: Joanne Martin 07713744054 J.e.martin@qmul.ac.uk

Locations
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United Kingdom
Queen Mary University London
London, United Kingdom, E1 2ES
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Study Chair: Joanne Martin Queen Mary University London
Publications:
Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020
University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19
Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020
World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020
Department of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020
Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results
Primerdesign™ Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. Instructions for Use. Issue 1.01. 20th March 2020. Available at: https://www.fda.gov/media/136309/download (page 21)
NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT04453553    
Other Study ID Numbers: 285524
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Queen Mary University of London:
COVID-19