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Nasal Photodisinfection COVID-19 Proof of Concept Study

Not Applicable
Completed
Conditions
COVID-19
SARS-CoV 2
Corona Virus Infection
Interventions
Other: Methylene-Blue Photodisinfection
Registration Number
NCT04615936
Lead Sponsor
Sunnybrook Health Sciences Centre
Brief Summary

The study proposes to test photodisinfection (PDF) on SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in he nostril of patients infected with SARS-CoV-2. Participants are swabbed for SARS-CoV-2 before and after the PDF treatment. For the study, a small group of healthcare workers who have tested positive for SARS-CoV-2 will be included. They will not undergo the treatment but will need to swab their noses multiple times over the next 5 days. This nil group will provide the effect (if any) of swabbing SARS-CoV-2 levels in the nose.

Detailed Description

The study proposes to test photodisinfetion (PDF) on levels of SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in patients infected with SARS-CoV-2 . Currrently, PDF is being used at some institutions before surgery to lower the risk of postoperative infection. PDF uses a Methylene Blue (MB) nasal spray, followed by 5 minutes of red-light exposure through a small light-diffusing applicator. This will need to be placed into each nostril. Participants are swabbed for SARS-CoV-2 before and after treatment. In addition to the patients testing positive for SARS-CoV-2, there will also be a small group of healthcare workers who have tested positive that will be included. Though they are not undergoing treatment, they will swab their own noses multiple times over a period of 5 days. This will allow us to evaluate the effect (if any) of swabbing on SARS-CoV-2 levels in the nose. The study hypothesis is that MB-mediated PDF will show the ability to kill SARS-CoV-2 which will consequently confirm its efficacy as a first line defense against the virus.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Methylene Blue-PhotodisinfectionMethylene-Blue PhotodisinfectionThe Health-Canada approved Steriwave system (Ondine Biomedical, BC) will be used to deliver the Methylene Blue-Photodisinfection (MB-PDF) to the anterior nares.
Primary Outcome Measures
NameTimeMethod
RT-qPCR30 minutes

The main endpoint is microbiological; RT-qPCR will be conducted on the pre and post treatment swabs and the change in cycle threshold value will be measured

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

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