COVID-19NCT04615936
Nasal Photodisinfection COVID-19 Proof of Concept Study
A study testing Methylene-Blue Photodisinfection in people with COVID-19 and Corona Virus Infection, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Corona Virus Infection, SARS-CoV 2
- What is being tested?
- Methylene-Blue Photodisinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2020to 19 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recent SARS-CoV-2+ diagnosis
- Present in hospital
- Recent SARS-CoV-2+ diagnosis
- Ability to self-administer nasal swabs
Who cannot join
- Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Corona Virus Infection, SARS-CoV 2
- Being tested
- Methylene-Blue Photodisinfection
- Keywords
- COVID-19, SARS-CoV-2, coronavirus, influenza, photodisinfection, nasal photodisinfection
- Medical subject headings
- COVID-19, Coronavirus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene-Blue PhotodisinfectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Methylene-Blue Photodisinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start13 Oct 2020
- Primary completion7 Jul 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cari Whyne, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615936
- Sponsor's protocol ID
- NasalPDF001
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35304729
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylene Blue-mediated Photodisinfection for SARS-CoV-2 in the Upper Respiratory Tract
- ClinicalTrials.gov ID
- NCT04615936
- Acronym / sponsor ID
- NasalPDF001
- Conditions
- COVID-19, Corona Virus Infection, SARS-CoV 2
- Keywords
- COVID-19, SARS-CoV-2, coronavirus, influenza, photodisinfection, nasal photodisinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue-Photodisinfection | Experimental | Other: Methylene-Blue PhotodisinfectionThe Health-Canada approved Steriwave system (Ondine Biomedical, BC) will be used to deliver the Methylene Blue-Photodisinfection (MB-PDF) to the anterior nares. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Recent SARS-CoV-2+ diagnosis
- Present in hospital
- Recent SARS-CoV-2+ diagnosis
- Ability to self-administer nasal swabs
Key exclusion criteria (2 listed)
- Immediate requirement for intubation (i.e. emergency airway) or inability to maintain independent oral airway
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene-Blue PhotodisinfectionParticipants 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. | Other | Methylene Blue-Photodisinfection |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 35304729Lobo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cari Whyne, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene-Blue Photodisinfection in people with COVID-19 and Corona Virus Infection, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RT-qPCR (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.