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Nasal Photodisinfection COVID-19 Proof of Concept Study

NCT ID: NCT04615936

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-10-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Corona Virus Infection SARS-CoV 2

Keywords

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COVID-19 SARS-CoV-2 coronavirus influenza photodisinfection nasal photodisinfection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

N/A- masking not required

Study Groups

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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.

Group Type EXPERIMENTAL

Methylene-Blue Photodisinfection

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Recent SARS-CoV-2+ diagnosis
* Present in hospital


* Recent SARS-CoV-2+ diagnosis
* Ability to self-administer nasal swabs

Exclusion Criteria

* Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway


* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cari Whyne, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35304729 (View on PubMed)

Other Identifiers

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NasalPDF001

Identifier Type: -

Identifier Source: org_study_id