- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084898
Far-UVC Light Devices in Long-term Care Facilities to Reduce Infections (UVCinLTCs)
Do Far-UVC Light Devices Reduce the Incidence of Influenza-Like Illnesses, Respiratory Illnesses, and COVID-19 Infections in Long-term Care Facilities?
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, b3k3s5
- Northwood Halifax Campus
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Windsor, Nova Scotia, Canada, b0p1l0
- Windsor Elms Village
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention
Far-UVC light as an additional method of disinfection
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Far-UVC light is a form of ultraviolet light with an extremely short wavelength (207-222 nm)
|
Placebo Comparator: Placebo
"Inactive" fluorescent light (no additional disinfection)
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"Inactive" fluorescent light (no additional disinfection)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Over 2 flu seasons, approximately 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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From the date of diagnosis until the date of recovery or date of death, whichever comes first, assessed up to 30 days.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenneth Rockwood, MD, Nova Scotia Health Authority
Publications and helpful links
General Publications
- Liu K, Chen Y, Lin R, Han K. Clinical features of COVID-19 in elderly patients: A comparison with young and middle-aged patients. J Infect. 2020 Jun;80(6):e14-e18. doi: 10.1016/j.jinf.2020.03.005. Epub 2020 Mar 27.
- Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Armitage R, Nellums LB. COVID-19 and the consequences of isolating the elderly. Lancet Public Health. 2020 May;5(5):e256. doi: 10.1016/S2468-2667(20)30061-X. Epub 2020 Mar 20. No abstract available.
- Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implement Sci. 2016 May 17;11:72. doi: 10.1186/s13012-016-0437-z.
- Moberg J, Kramer M. A brief history of the cluster randomised trial design. J R Soc Med. 2015 May;108(5):192-8. doi: 10.1177/0141076815582303. No abstract available.
- Andrew M, Searle SD, McElhaney JE, McNeil SA, Clarke B, Rockwood K, Kelvin DJ. COVID-19, frailty and long-term care: Implications for policy and practice. J Infect Dev Ctries. 2020 May 31;14(5):428-432. doi: 10.3855/jidc.13003.
- Austin PC. A Tutorial on Multilevel Survival Analysis: Methods, Models and Applications. Int Stat Rev. 2017 Aug;85(2):185-203. doi: 10.1111/insr.12214. Epub 2017 Mar 24.
- Buonanno M, Welch D, Shuryak I, Brenner DJ. Far-UVC light (222 nm) efficiently and safely inactivates airborne human coronaviruses. Sci Rep. 2020 Jun 24;10(1):10285. doi: 10.1038/s41598-020-67211-2. Erratum In: Sci Rep. 2021 Sep 27;11(1):19569.
- Garner R, Tanuseputro P, Manuel DG, Sanmartin C. Transitions to long-term and residential care among older Canadians. Health Rep. 2018 May 16;29(5):13-23.
- Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med. 2018 Feb 28;16(1):29. doi: 10.1186/s12916-018-1017-7.
- Welch D, Buonanno M, Grilj V, Shuryak I, Crickmore C, Bigelow AW, Randers-Pehrson G, Johnson GW, Brenner DJ. Far-UVC light: A new tool to control the spread of airborne-mediated microbial diseases. Sci Rep. 2018 Feb 9;8(1):2752. doi: 10.1038/s41598-018-21058-w. Erratum In: Sci Rep. 2021 Sep 7;11(1):18122.
- Liu Y, Mao B, Liang S, Yang JW, Lu HW, Chai YH, Wang L, Zhang L, Li QH, Zhao L, He Y, Gu XL, Ji XB, Li L, Jie ZJ, Li Q, Li XY, Lu HZ, Zhang WH, Song YL, Qu JM, Xu JF; Shanghai Clinical Treatment Experts Group for COVID-19. Association between age and clinical characteristics and outcomes of COVID-19. Eur Respir J. 2020 May 27;55(5):2001112. doi: 10.1183/13993003.01112-2020. Print 2020 May.
- Simard J, Volicer L. Loneliness and Isolation in Long-term Care and the COVID-19 Pandemic. J Am Med Dir Assoc. 2020 Jul;21(7):966-967. doi: 10.1016/j.jamda.2020.05.006. Epub 2020 May 8. No abstract available.
- El Haj M, Altintas E, Chapelet G, Kapogiannis D, Gallouj K. High depression and anxiety in people with Alzheimer's disease living in retirement homes during the covid-19 crisis. Psychiatry Res. 2020 Sep;291:113294. doi: 10.1016/j.psychres.2020.113294. Epub 2020 Jul 13.
- Falsey AR, Baran A, Walsh EE. Should clinical case definitions of influenza in hospitalized older adults include fever? Influenza Other Respir Viruses. 2015 Aug;9 Suppl 1(Suppl 1):23-9. doi: 10.1111/irv.12316.
- Sayers G, Igoe D, Carr M, Cosgrave M, Duffy M, Crowley B, O'Herlihy B. High morbidity and mortality associated with an outbreak of influenza A(H3N2) in a psycho-geriatric facility. Epidemiol Infect. 2013 Feb;141(2):357-65. doi: 10.1017/S0950268812000659. Epub 2012 Apr 17.
- Drinka PJ, Krause P, Nest L, Gravenstein S, Goodman B, Shult P. Delays in the application of outbreak control prophylaxis for influenza A in a nursing home. Infect Control Hosp Epidemiol. 2002 Oct;23(10):600-3. doi: 10.1086/501978.
- Mahmud SM, Thompson LH, Nowicki DL, Plourde PJ. Outbreaks of influenza-like illness in long-term care facilities in Winnipeg, Canada. Influenza Other Respir Viruses. 2013 Nov;7(6):1055-61. doi: 10.1111/irv.12052. Epub 2012 Nov 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Orthomyxoviridae Infections
- COVID-19
- Infections
- Communicable Diseases
- Influenza, Human
- Respiratory Tract Infections
Other Study ID Numbers
- 32906-UVC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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