Nasal Photodisinfection COVID-19 Proof of Concept Study

NCT04615936 | Completed

• 1 other identifier: NasalPDF001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Corona Virus Infection; SARS-CoV 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  30 minutes

Study Arms (1)

Methylene Blue-Photodisinfection

EXPERIMENTAL

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

Interventions

Methylene-Blue Photodisinfection 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.

Methylene Blue-Photodisinfection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent SARS-CoV-2+ diagnosis
• Present in hospital
• Recent SARS-CoV-2+ diagnosis
• Ability to self-administer nasal swabs

You may not qualify if:

• Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway
• None

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 35304729 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Cari Whyne, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A- masking not required
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: October 13, 2020
• Primary Completion: July 7, 2021
• Study Completion: October 19, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

CA (1)