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Far-UVC Light Devices in Long-term Care Facilities to Reduce Infections (UVCinLTCs)

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. Read our disclaimer for details. Identifier: NCT05084898
Recruitment Status : Unknown
Verified October 2021 by Kenneth Rockwood, Nova Scotia Health Authority.
Recruitment status was:  Enrolling by invitation
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Department of Health, Nova Scotia
Research Nova Scotia
Nova Scotia Health Authority
Information provided by (Responsible Party):
Kenneth Rockwood, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE January 26, 2021
First Posted Date  ICMJE October 20, 2021
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
A diagnosis of COVID-19 or other respiratory viral infection [ Time Frame: Over 2 flu seasons, approximately 24 months ]
Diagnosis will be based on positive laboratory finding of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, or other respiratory viral infections (as per available testing). Testing will be performed on nasal swabs collected from participants who are positive for any of the symptoms in the screening protocol.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
Time to recovery or death [ Time Frame: From the date of diagnosis until the date of recovery or date of death, whichever comes first, assessed up to 30 days. ]
Number of days from diagnosis of respiratory viral infection until recovery or death. Participant will be deemed "recovered" once their overall health status (vital, functional, and cognitive) has been stable for one week. This return to stable state will be determined by participant's clinical care team and is part of usual care.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Far-UVC Light Devices in Long-term Care Facilities to Reduce Infections
Official Title  ICMJE Do Far-UVC Light Devices Reduce the Incidence of Influenza-Like Illnesses, Respiratory Illnesses, and COVID-19 Infections in Long-term Care Facilities?
Brief Summary

Elderly people who have multiple health problems are at higher risk of illness from viral respiratory infections, such as influenza (the flu) and COVID-19. This is especially true for residents in long-term care because the usual methods of infection control (handwashing, mask-wearing, and distancing) are difficult to enforce due to the memory problems of many residents and the frequently shared common spaces. It can also be difficult to prevent the spread of viral infections within long-term care because many residents are unable to tell their caregivers when they are feeling ill. Also, some elderly people do not show typical symptoms of infection (like fever), instead they may suddenly become confused or weak.

This study will test if a safe form of ultraviolet light (far-UVC) can be effective as an extra method of disinfection (in addition to usual manual cleaning) against airborne and surface viruses that can cause respiratory infections.

Detailed Description

Background: Nova Scotia has the highest proportion of seniors in Canada. Investing in high quality and safe long-term care homes is considered an important healthy aging strategy both here and globally. COVID-19 has disproportionately affected the elderly population, especially those with underlying health conditions. Residents of long-term care (LTC) facilities have been particularly vulnerable during this pandemic in Canada and elsewhere. Several approaches have been mandated to mitigate the high transmissibility of the aerosolised SARS-CoV-2 coronavirus. These are guided by three key principles: minimize time of exposure, maximize distance from sources of virus and finally to shield self from virus. As demonstrated in emerging evidence, these can be effective measures provided ability for compliance and human behaviours. Following life-saving public health guidelines has proven monumentally challenging in LTC facilities, due to the high prevalence of dementia and frailty. These severe public health measures and common infection control measures have resulted in other negative consequences for LTC residents, such as an increased feeling of loneliness, depression, and mental illnesses.

A further challenge with this population is early recognition of RVI in LTC residents can be difficult due to non-specific symptoms and the possibility of atypical presentation and lack of fever in the elderly with influenza. In this population, RVI can present as sudden, unexplained deterioration in physical or mental ability or exacerbation of an underlying condition with no other known cause. Additionally, other underlying conditions could impair residents' abilities to verbalize their symptoms. This could result in delays to the implementation of control and treatment strategies.

Rational: Far-UVC is emerging as a safe form of ultraviolet light disinfectant to kill airborne viral transmissions, including SARS CoV-2 virus. Far-UVC light (207-222 nm) in low doses effectively kills pathogens without damaging exposed human tissues. Preliminary data suggests using the regulatory safe level of exposure of lower dose UVC light (far-UVC light) can inactivate >95% of aerosolized H1N1 influenza virus and 90 percent of human coronaviruses in 8 minutes and almost 100 percent in 25 minutes. Despite growing evidence on far-UVC as a safe and viable infection control strategy, there is limited research on the feasibility, acceptability and efficacy of far-UVC in LTC settings.

Main Objective: To determine whether far-UVC light causes a reduction in the incidence of influenza-like illnesses, respiratory infections, and COVID-19 infections, among residents in long term care facilities.

Methodology: This is a cluster randomized control trial designed to identify superiority of the intervention. Residents of two LTC facilities, will be cluster-randomized based on the 'neighbourhoods' they live in (social groups of 18-36) with a 1:1 allocation ratio. Randomization will be stratified by the LTC facility. Neighbourhoods will be randomly assigned to have either far-UVC lights installed in common areas (treated) or matching placebo lights without far-UVC capabilities (control). Both groups will still receive standard disinfecting procedures and are subject to Nova Scotia's COVID prevention measures. The far-UVC and fluorescent lights will be placed in high traffic areas (e.g. dining rooms, main corridors). Residents spend approximately 3-4 hours daily in these common areas. The far-UVC lamps will be kept within wavelengths (207-222 nm) and exposure times that have been demonstrated to be safe for use among elderly populations. The trial period will span over 1-2 flu seasons to allow for sufficient data and sample size to describe the efficacy and sustainability of the far-UVC intervention. To be responsive to key policy and planning needs during post pandemic times, findings will be presented routinely to advisory council members and to relevant stakeholders in the province.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Residents of two LTC facilities, will be cluster-randomized based on the 'neighbourhoods' they live in (social groups of 18-36) with a 1:1 allocation ratio. Randomization will be stratified by the LTC facility.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

BIinding in this study involves the use of a placebo arm. The placebo lamps will look exactly like the active far-UVC lamps, but they will produce regular fluorescent light and have no disinfection properties.

The trial will be blinded to everyone involved in the study except for one member of the lead coordinating team who must remain unblinded to provide lamp allocation guidance to the installing electricians. This person will not be involved in data collection or analysis, nor will they have access to participant identifying information, only their deidentified study ID.

Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19 Respiratory Infection
  • Respiratory Virus Infection
  • Influenza -Like Illness
Intervention  ICMJE
  • Other: Far-UVC light as an additional method of disinfection
    Far-UVC light is a form of ultraviolet light with an extremely short wavelength (207-222 nm)
  • Other: Placebo fluorescent light
    "Inactive" fluorescent light (no additional disinfection)
Study Arms  ICMJE
  • Active Comparator: Intervention
    Far-UVC light as an additional method of disinfection
    Intervention: Other: Far-UVC light as an additional method of disinfection
  • Placebo Comparator: Placebo
    "Inactive" fluorescent light (no additional disinfection)
    Intervention: Other: Placebo fluorescent light
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 6, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Exclusion Criteria: LTC residents who do not consent to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05084898
Other Study ID Numbers  ICMJE 32906-UVC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kenneth Rockwood, Nova Scotia Health Authority
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kenneth Rockwood
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Department of Health, Nova Scotia
  • Research Nova Scotia
  • Nova Scotia Health Authority
Investigators  ICMJE
Principal Investigator: Kenneth Rockwood, MD Nova Scotia Health Authority
PRS Account Nova Scotia Health Authority
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP