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

Primary Purpose

COVID-19 Respiratory Infection, Respiratory Virus Infection, Influenza -Like Illness

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Far-UVC light as an additional method of disinfection
Placebo fluorescent light
Sponsored by
Kenneth Rockwood
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Respiratory Infection focused on measuring Far-UVC, long-term care, respiratory illnesses, disinfection methods, viral infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers
Exclusion Criteria: LTC residents who do not consent to participate

Sites / Locations

  • Northwood Halifax Campus
  • Windsor Elms Village

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Far-UVC light as an additional method of disinfection

"Inactive" fluorescent light (no additional disinfection)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 26, 2021
Last Updated
October 6, 2021
Sponsor
Kenneth Rockwood
Collaborators
Department of Health, Nova Scotia, Research Nova Scotia, Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05084898
Brief Title
Far-UVC Light Devices in Long-term Care Facilities to Reduce Infections
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Rockwood
Collaborators
Department of Health, Nova Scotia, Research Nova Scotia, Nova Scotia Health Authority

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection, Respiratory Virus Infection, Influenza -Like Illness
Keywords
Far-UVC, long-term care, respiratory illnesses, disinfection methods, viral infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Far-UVC light as an additional method of disinfection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
"Inactive" fluorescent light (no additional disinfection)
Intervention Type
Other
Intervention Name(s)
Far-UVC light as an additional method of disinfection
Intervention Description
Far-UVC light is a form of ultraviolet light with an extremely short wavelength (207-222 nm)
Intervention Type
Other
Intervention Name(s)
Placebo fluorescent light
Intervention Description
"Inactive" fluorescent light (no additional disinfection)
Primary Outcome Measure Information:
Title
A diagnosis of COVID-19 or other respiratory viral infection
Description
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.
Time Frame
Over 2 flu seasons, approximately 24 months
Secondary Outcome Measure Information:
Title
Time to recovery or death
Description
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.
Time Frame
From the date of diagnosis until the date of recovery or date of death, whichever comes first, assessed up to 30 days.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria: LTC residents who do not consent to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Rockwood, MD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwood Halifax Campus
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
b3k3s5
Country
Canada
Facility Name
Windsor Elms Village
City
Windsor
State/Province
Nova Scotia
ZIP/Postal Code
b0p1l0
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Far-UVC Light Devices in Long-term Care Facilities to Reduce Infections

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