跳至主要内容
临床试验/NCT05084898
NCT05084898已完成不适用

Do Far-UVC Light Devices Reduce the Incidence of Respiratory Viral Illness in Long-term Care Facilities?

Kenneth Rockwood5 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
550
试验地点
5
主要终点
A diagnosis of COVID-19 or other respiratory viral infection

研究概览

简要总结

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.

详细描述

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 three 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 222 nm 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 at a wavelength of 222 nm and exposure times that have been demonstrated to be safe for use among elderly populations. The trial period will span over 2-3 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

性别
All
接受健康志愿者

入选标准

  • Exclusion Criteria: LTC residents who do not consent to data collection

排除标准

  • LTC residents who do not consent to data collection

研究组 & 干预措施

Intervention

Active Comparator

Far-UVC light as an additional method of disinfection

干预措施: Far-UVC light as an additional method of disinfection (Other)

Placebo

Placebo Comparator

"Inactive" fluorescent light (no additional disinfection)

干预措施: Placebo fluorescent light (Other)

结局指标

主要结局

A diagnosis of COVID-19 or other respiratory viral infection

时间窗: Over 3 flu seasons, approximately 28 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.

次要结局

  • Time to recovery or death(From the date of diagnosis until the date of recovery or date of death, whichever comes first, assessed up to 30 days.)

研究者

发起方
Kenneth Rockwood
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kenneth Rockwood

Geriatrician

Nova Scotia Health Authority

研究点 (5)

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