Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615936
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2020-11-02
Brief Title:
Nasal Photodisinfection COVID-19 Proof of Concept Study
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Methylene Blue-mediated Photodisinfection for SARS-CoV-2 in the Upper Respiratory Tract
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None