Nasal Photodisinfection COVID-19 Proof of Concept Study

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: COVID-19; SARS-CoV 2; Corona Virus Infection

Treatments: Other: Methylene-Blue Photodisinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT04615936

NasalPDF001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (patient population):

• Recent SARS-CoV-2+ diagnosis
• Present in hospital

Inclusion Criteria (healthcare workers):

• Recent SARS-CoV-2+ diagnosis
• Ability to self-administer nasal swabs

Exclusion Criteria (patient population):

• Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway

Exclusion Criteria (healthcare workers):

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Methylene Blue-Photodisinfection

Experimental group

Description:

The Health-Canada approved Steriwave system (Ondine Biomedical, BC) will be used to deliver the Methylene Blue-Photodisinfection (MB-PDF) to the anterior nares.

Treatment:

Other: Methylene-Blue Photodisinfection