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

COVID-19 Respiratory Infection Clinical Trial

— UVCinLTCs  

Official title:

Do Far-UVC Light Devices Reduce the Incidence of Influenza-Like Illnesses, Respiratory Illnesses, and COVID-19 Infections in Long-term Care Facilities?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05084898
• Other study ID #: 32906-UVC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older
• Eligibility: Exclusion Criteria: LTC residents who do not consent to participate

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza -Like Illness
• Influenza, Human
• Respiratory Tract Infections
• Respiratory Virus Infection

Intervention

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)
• Placebo fluorescent light
"Inactive" fluorescent light (no additional disinfection)

Locations

Country	Name	City	State
Canada	Northwood Halifax Campus	Halifax	Nova Scotia
Canada	Windsor Elms Village	Windsor	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
Kenneth Rockwood	Department of Health, Nova Scotia, Nova Scotia Health Authority, Research Nova Scotia

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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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. — View Citation

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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). pii: 2001112. doi: 10.1183/13993003.01112-2020. Print 2020 May. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A diagnosis of COVID-19 or other respiratory viral infection	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
Secondary	Time to recovery or death	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.	From the date of diagnosis until the date of recovery or date of death, whichever comes first, assessed up to 30 days.