Corona Virus Infection, COVID-19, SARS-CoV 2
Conditions
Keywords
COVID-19, SARS-CoV-2, coronavirus, influenza, photodisinfection, nasal photodisinfection
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.
Interventions
OTHERMethylene-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.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
N/A- masking not required
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RT-qPCR | 30 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 |
Countries
Canada
Outcome results
None listed