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Trial record 1 of 1 for:    222nm | COVID-19 | Canada
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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.
 
ClinicalTrials.gov Identifier: NCT05084898
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
Department of Health, Nova Scotia
Research Nova Scotia
Nova Scotia Health Authority
Information provided by (Responsible Party):
Kenneth Rockwood, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Infection Respiratory Virus Infection Influenza -Like Illness Other: Far-UVC light as an additional method of disinfection Other: Placebo fluorescent light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
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?
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : April 30, 2023


Arm Intervention/treatment
Active Comparator: Intervention
Far-UVC light as an additional method of disinfection
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 Comparator: Placebo
"Inactive" fluorescent light (no additional disinfection)
Other: Placebo fluorescent light
"Inactive" fluorescent light (no additional disinfection)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Exclusion Criteria: LTC residents who do not consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084898


Locations
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Canada, Nova Scotia
Northwood Halifax Campus
Halifax, Nova Scotia, Canada, b3k3s5
Windsor Elms Village
Windsor, Nova Scotia, Canada, b0p1l0
Sponsors and Collaborators
Kenneth Rockwood
Department of Health, Nova Scotia
Research Nova Scotia
Nova Scotia Health Authority
Investigators
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Principal Investigator: Kenneth Rockwood, MD Nova Scotia Health Authority
Publications:

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Responsible Party: Kenneth Rockwood, Geriatrician, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT05084898    
Other Study ID Numbers: 32906-UVC
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Kenneth Rockwood, Nova Scotia Health Authority:
Far-UVC
long-term care
respiratory illnesses
disinfection methods
viral infections
Additional relevant MeSH terms:
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COVID-19
Infections
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections