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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylene Blue-Photodisinfection | Experimental | The Health-Canada approved Steriwave system (Ondine Biomedical, BC) will be used to deliver the Methylene Blue-Photodisinfection (MB-PDF) to the anterior nares. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene-Blue Photodisinfection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| RT-qPCR | 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 | 30 minutes |
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Inclusion Criteria (patient population):
Inclusion Criteria (healthcare workers):
Exclusion Criteria (patient population):
Exclusion Criteria (healthcare workers):
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| Name | Affiliation | Role |
|---|---|---|
| Cari Whyne, PhD | Sunnybrook Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35304729 | Derived | Lobo CS, Rodrigues-Santos P, Pereira D, Nunez J, Trepa JCD, Sousa DL, Lourenco JV, Coelho MF, de Almeida LP, da Cunha JS, Arnaut LG. Photodynamic disinfection of SARS-CoV-2 clinical samples using a methylene blue formulation. Photochem Photobiol Sci. 2022 Jun;21(6):1101-1109. doi: 10.1007/s43630-022-00202-6. Epub 2022 Mar 19. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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There is only a single group of patients in the study who will undergo treatment. There is a small sub group/'nil' group of 3 healthcare workers that will not be undergoing the treatment but will instead be doing multiple nasal swabbing in the course of 5 days.
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N/A- masking not required
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|
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |