NCT04615936

Nasal Photodisinfection COVID-19 Proof of Concept Study

Methylene Blue-mediated Photodisinfection for SARS-CoV-2 in the Upper Respiratory Tract

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Corona Virus Infection
• SARS-CoV 2

Interventions

Type	Name	Description
OTHER	Methylene-Blue Photodisinfection	Participants will receive a pre-treatment nasal swab followed MB-PDF, this involves an MB nasal spray, followed by five minutes of red-light exposure into each nostril. Ten minutes after the treatment, a post treatment nasal swab will be performed.

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-07-07
• Completion: 2021-10-19
• First posted: 2020-11-04
• Last updated: 2021-11-08

Locations

1 site across 1 country: Canada