An interventional study of Methylene-Blue Photodisinfection in COVID-19, Corona Virus Infection and SARS-CoV 2, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Inclusion Criteria (patient population):
Inclusion Criteria (healthcare workers):
Exclusion Criteria (patient population):
Exclusion Criteria (healthcare workers):
The Health-Canada approved Steriwave system (Ondine Biomedical, BC) will be used to deliver the Methylene Blue-Photodisinfection (MB-PDF) to the anterior nares.
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.
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
Time frame: 30 minutes
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre