Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000791538
Ethics application status
Approved
Date submitted
8/05/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of germicidal ultraviolet Light in an Upper room Configuration In Decreasing COVID-19 in Aged-care Residential facilities (ELUCIDAR): A cluster randomised controlled trial
Scientific title
Effectiveness of upper room germicidal ultraviolet light in decreasing COVID-19 among residents of aged-care facilities (ELUCIDAR): An open-label cluster randomised controlled trial
Secondary ID [1] 312103 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ELUCIDAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 333737 0
Influenza A 333738 0
Respiratory Syncytial Virus (RSV) 333739 0
Influenza B 334055 0
Condition category
Condition code
Infection 330421 330421 0 0
Studies of infection and infectious agents
Respiratory 330422 330422 0 0
Other respiratory disorders / diseases
Public Health 330423 330423 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to determine if, in Residential Aged Care Facilities (RACFs) in metropolitan Melbourne and Greater Geelong, Victoria, Australia, the installation of upper room germicidal ultraviolet light luminaires (UR-GUV) in common areas reduces the event rate of COVID-19 among residents, compared to standard practices alone, over 12 months. This is an open-label cluster randomised controlled trial (cRCT) conducted in a real-world setting.

Enrollment and randomisation will occur at the RACF level, which are the clusters. Following engagement, provision of information to RACF management, staff and residents, facility management or providers (companies who are the owners) will enter an agreement to participate in the trial with the Victorian Department of Health. Individual consent will not be obtained. The study will aim to have 30 RACFs in the intervention arm and 30 in the control arm. Following randomisation (group allocation), installation will be completed in all intervention facilities. The study period commences when the intervention commences, ie, UR-GUV luminaires will be simultaneously turned on in all intervention facilities to operate continuously and concludes after 12 months.

Intervention (arm 1) = Upper room germicidal ultraviolet lights (UVC 254nm wavelength), in addition to standard infection control measures (as described in the standard of care arm 2).

Description:

This study involves installing UR-GUV onto the ceilings or high on the walls in the intervention facilities.

The UR-GUV lights will emit ultraviolet-C (UVC) irradiation at the 254nm wavelength, which has been shown to reduce the transmission of airborne pathogens, such as tuberculosis and inactivate SARS-CoV-2 and influenza viruses in the laboratory.

When the devices are turned on, this creates a zone of disinfection at the top of the room, while people can safely spend time in the occupied part of the room below without detectable UV light exposure, as per established regulatory standards. Normal air circulation in the room will bring airborne pathogens into the disinfection zone, just below the ceiling, where the ultraviolet light is designed to inactivate them to prevent them from causing further infections.

Standardised parameters for UR-GUV installation have been developed to optimise efficacy while maintaining the safety of residents and staff and adhering to relevant standards.

Installation will be conducted by a single commercial supplier following agreements between the facility or provider management and the Victorian Department of Health.

The luminaires will be installed in common areas such as dining rooms and shared activity rooms.
A common area has a standardised operational definition that includes an area or room inside the RACF that includes criteria for open access, prolonged occupancy and clustered interactions. Examples include dining rooms, lounge or sitting rooms, or libraries.


Once UR-GUV installation in all intervention facilities is complete, the study will commence. The luminaires will be activated to operate continuously and data collection will commence and then be performed for a 12 month period. There are safety protocols and mechanisms in place that will allow the lights to be turned off by facilities for short periods to allow personal to enter the upper zone of the room when required (e.g. for maintenance, replacing light globes in other light fittings etc).
Remote monitoring of the lighting will be in place to allow for measuring light adherence. Additionally, facilities will be required, as per the trial operating procedures, to report any suspected device faults or safety incidences to the Department of Health and the UR-GUV luminaire supplier.

After commissioning UR-GUV in a RACF, the UR-GUV luminaire installer will conduct onsite checks every 12-weeks, confirming lamp operation and adherence, UV safety levels, and to clean the light fittings. The installer will also measure and ensure that the UV light levels achieved in the upper disinfection zone (at 2.3m height) are as expected. Measurements of UVC light levels will also be conducted at various points in the lower inhabited zone, at standing eye height (1.83 metres) to ensure no unsafe levels of UV light are produced.

Interventional facilities will use UR-GUV in addition to standard of care (see control group arm 2 for description).
Intervention code [1] 328541 0
Prevention
Intervention code [2] 328542 0
Treatment: Devices
Comparator / control treatment
Control (arm 2) = Standard of care

Description:
The comparator or control arm is standard of care for COVID-19 and acute respiratory infection prevention and control (IPC) as per Department of Health guidelines and the study standard operating procedures (SOPs).
This includes procedures for visitor restrictions and administrative controls, vaccination, ventilation, testing, outbreak management and personal protective equipment, including masks. RACFs will have variation in practices for ventilation, filtration (including use of portable high efficiency particulate or HEPA filters) and air mixing and this will be monitored and documented.

Standardisation of these IPC interventions will be detailed and enabled through the study SOP which all participating facilities will agree to follow. Ongoing engagement with RACF IPC leads will support compliance and monitoring of practices.
Control group
Active

Outcomes
Primary outcome [1] 338174 0
Primary outcome 1: COVID-19 event rate in residents per resident-bed-days at risk.
• COVID-19 events are defined using the case definition in the Victorian Department of Health guidelines.
• Microbiologically positive COVID-19 events (positive on PCR or rapid antigen test (RAT)) in residents of enrolled and randomised aged-care facilities reported during the study period.
• COVID-19 events that have been clinically determined to be historic cases or recently covered (occur within 35 days of the most recent previous COVID-19 event) are excluded.
Timepoint [1] 338174 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.
Secondary outcome [1] 434806 0
Composite event rate for COVID-19, Influenza A, Influenza B and/or RSV in residents and staff per resident-bed-days at risk.
This is a composite outcome that will also be disaggregated by pathogen and resident or staff events.
Timepoint [1] 434806 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.
Secondary outcome [2] 434807 0
: Size and number of COVID-19, influenza, and/or RSV outbreaks among residents and staff
This is a composite outcome that will also be disaggregated by pathogen and resident or staff events.
Defined as per Victorian public health surveillance guidelines for each pathogen
Timepoint [2] 434807 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.
Secondary outcome [3] 434808 0
Rate of hospitalisations associated with COVID-19, Influenza A, Influenza B and/or RSV among residents per resident-person-days at risk
This is a composite outcome that will also be disaggregated by pathogen.
Timepoint [3] 434808 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.
Secondary outcome [4] 434809 0
Rate of death associated with COVID-19, Influenza A, Influenza B and/or RSV among residents.
This is a composite outcome that will also be disaggregated by pathogen.
Timepoint [4] 434809 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.
Secondary outcome [5] 434810 0
Rate of death from all-causes among residents
Timepoint [5] 434810 0
12-month period commencing on the date when the GUV is turned on for the intervention arm.

Eligibility
Key inclusion criteria
• Public (administered by state or local governments), private, and not-for-profit facilities.
• Operational facilities with greater than or equal to 75 operational beds
• Located in metropolitan Melbourne or Greater Geelong municipalities in Victoria Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Facilities with layouts similar to a single cabin or self-contained unit layout.
• Non-operational facilities or facilities unable to participate for the entire 12-month study period (i.e. planned sale/acquisitions, or renovations)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised permuted blocks stratified by the provider (entities that own and operate several RACFs)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the study involving 30 facilities in each arm, with a significance level (alpha) of 0.05, the power is set at 90% to detect at least a 32% reduction in event rates due to the intervention, and at 80% power, a 28% reduction can be detected. The event rate was calculated from the number of COVID-19 cases reported during outbreaks in aged care facilities with at least 75 operational beds in 2023.


The primary outcome, the COVID-19 event rate, will be analyzed using a multilevel Poisson regression model. The denominator for calculating the event rate (offset in the Poisson model) person-days of occupancy of the RACF, which is equivalent to the person-days at risk. This model will include random effects for both the facility and individual, with the latter accounting for the possibility of multiple events in an individual. Appropriate regression diagnostics will be used, include testing for over-dispersion. A two-sided type-1 error rate of alpha=0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
6948
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316460 0
Government body
Name [1] 316460 0
The Victorian Department of Health
Country [1] 316460 0
Australia
Primary sponsor type
Government body
Name
The Victorian Department of Health
Address
Country
Australia
Secondary sponsor category [1] 318637 0
None
Name [1] 318637 0
Address [1] 318637 0
Country [1] 318637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315250 0
Department of Health and Department of Human Services Human Research Ethics Committee
Ethics committee address [1] 315250 0
Ethics committee country [1] 315250 0
Australia
Date submitted for ethics approval [1] 315250 0
12/01/2024
Approval date [1] 315250 0
07/03/2024
Ethics approval number [1] 315250 0
105310

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134134 0
Dr Michelle Delaire
Address 134134 0
Department of Health 50 Lonsdale Street Melbourne Victoria 3000
Country 134134 0
Australia
Phone 134134 0
+61 429 488 190
Fax 134134 0
Email 134134 0
[email protected]
Contact person for public queries
Name 134135 0
Michelle Delaire
Address 134135 0
Department of Health 50 Lonsdale Street Melbourne Victoria 3000
Country 134135 0
Australia
Phone 134135 0
+61 1300 650 172
Fax 134135 0
Email 134135 0
[email protected]
Contact person for scientific queries
Name 134136 0
Associate Professor Suman Majumdar ( co-Principle Investigator)
Address 134136 0
Burnet Institute 85 Commercial Road Melbourne Victoria 3004
Country 134136 0
Australia
Phone 134136 0
+613 9282 2100
Fax 134136 0
Email 134136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data underlying published results after de-identification
When will data be available (start and end dates)?
Immediately following publication and no end date.
Available to whom?
On application, with a methodologically sounds research proposal (non-commercial) at the discretion of the sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.