Nasal Photodisinfection COVID-19 Proof of Concept Study

October 29, 2021 updated by: Sunnybrook Health Sciences Centre

Methylene Blue-mediated Photodisinfection for SARS-CoV-2 in the Upper Respiratory Tract

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylene Blue-Photodisinfection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RT-qPCR
Time Frame: 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
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Cari Whyne, PhD, Sunnybrook Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

July 7, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NasalPDF001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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