COVID-19 Respiratory InfectionNCT05184205
Photodynamic Therapy for COVID-19 Prevention
A study testing Nasal Photodisinfection in people with COVID-19 Respiratory Infection and SARS-CoV-2 Acute Respiratory Disease, run by Ondine Biomedical Inc. at 1 site in Spain.
Trial summary
This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Respiratory Infection, SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Nasal Photodisinfection
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2021to 30 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years of age
- Patient showing a positive test for SARS-CoV-2 with < 26 Ct of an FDA-approved PCR test who is symptomatic or flu-like illness or pneumonia
- Ability to tolerate an 12-minute non-painful nasal light illumination
Who cannot join
- Inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants
- Known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate.
- COVID-19 illness that is moderate or severe in nature.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photodynamic Therapy for SARS-CoV-2 Viral Reduction in the Upper Airway in PCR-positive Asymptomatic Individuals.
This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.
Read the detailed description
There is a wide variety of people who test positive for SARS-CoV-2. This is directly dependent upon their exposure to the virus, their age and any medical comorbidities that they may have. At this time, it is not possible to predict who will have an adequate immune response to avoid getting COVID-19. Since this remains unpredictable a universal approach to treating SARS-CoV-2 positive patients may be the optimal approach.
The rational for this study design is that in a real world setting numerous patients across a wide variety of conditions will receive testing for SARS-CoV-2 for a variety of reasons. For those who test positive and are asymptomatic or have only mild symptoms, the current standard of care is observation and quarantine. The incubation period can range from 2-14 days with a mean of 5-6 days. Depending upon an individual's original inoculum of virus, comorbidities and other factors they may progress to COVID-19. Preemptive treatment during this time frame may avoid or mitigate COVID-19 disease severity. In certain high-risk individuals attenuating the disease may avoid hospitalization or death, ICU admission and shorten hospital stays.
The nasal disinfection process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. The topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. The red light is absorbed by the photosensitizer molecules, causing electronic state transitions within the photosensitizer. The excited photosensitizer immediately transfers energy to surrounding molecular oxygen, thereby producing reactive oxygen species (ROS) that are responsible for the lethal cell wall disruption.
- Being tested
- Nasal Photodisinfection, Sham Comparator: Control
- Keywords
- SARS-CoV-2, antimicrobial photodynamic therapy (aPDT), COVID-19, viral load, Nasal decolonization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal PhotodisinfectionDevice
The procedure is initiated by swabbing the Formulation Applicator, pre-saturated with photosensitizer formulation, inside the patient's nares. The operator then connects the Nasal Light Illuminator (NLI) to the Light Source and inserts the NLIs into the patient's nostrils. The Light Source is turned on, and a 4-minute illumination cycle provides two channels of diffused red light (one for each nostril) to activate the applied formulation. Illumination stops automatically upon completion of the 4-minute cycle. The process is then repeated using two new Formulation Applicators to ensure full disinfection coverage.
Sham Comparator: ControlDevice
Patients who are SARS-CoV-2 positive whose PCR levels are followed but no active intervention will be done. Saline will be used in their nose and the light device will be inserted but not turned on. Patient will be wearing light protecting glasses.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | The procedure is initiated by swabbing the Formulation Applicator, pre-saturated with photosensitizer formulation, inside the patient's nares. The operator then connects the Nasal Light Illuminator (NLI) to the Light Source and inserts the NLIs into the patient's nostrils. The Light Source is turned on, and a 4-minute illumination cycle provides two channels of diffused red light (one for each nostril) to activate the applied formulation. Illumination stops automatically upon completion of the 4-minute cycle. The process is then repeated using two new Formulation Applicators to ensure full disinfection coverage. Receives: Device: Nasal Photodisinfection |
| Sham Comparator: Control | Sham comparator | Sham comparator Receives: Device: Sham Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 viral titer reduction
Change from baseline PCR count with testing on days 3, 7 and 14
Measured: Immediately following treatment and on days 3, 7, and 14.
Secondary outcomes (1)
General safety of nasal photodisinfection
Observation for any adverse events
Measured: 14 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (PDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondine Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Josepmaria Argemi, MD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184205
- Sponsor's protocol ID
- SARS_PDT01
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for SARS-CoV-2 Viral Reduction in the Upper Airway in PCR-positive Asymptomatic Individuals.
- ClinicalTrials.gov ID
- NCT05184205
- Acronym / sponsor ID
- SARS_PDT01
- Keywords
- SARS-CoV-2, antimicrobial photodynamic therapy (aPDT), COVID-19, viral load, Nasal decolonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ondine Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Navarra
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 11 Jan 2022 (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.
This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.
Detailed description
There is a wide variety of people who test positive for SARS-CoV-2. This is directly dependent upon their exposure to the virus, their age and any medical comorbidities that they may have. At this time, it is not possible to predict who will have an adequate immune response to avoid getting COVID-19. Since this remains unpredictable a universal approach to treating SARS-CoV-2 positive patients may be the optimal approach.
The rational for this study design is that in a real world setting numerous patients across a wide variety of conditions will receive testing for SARS-CoV-2 for a variety of reasons. For those who test positive and are asymptomatic or have only mild symptoms, the current standard of care is observation and quarantine. The incubation period can range from 2-14 days with a mean of 5-6 days. Depending upon an individual's original inoculum of virus, comorbidities and other factors they may progress to COVID-19. Preemptive treatment during this time frame may avoid or mitigate COVID-19 disease severity. In certain high-risk individuals attenuating the disease may avoid hospitalization or death, ICU admission and shorten hospital stays.
The nasal disinfection process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. The topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. The red light is absorbed by the photosensitizer molecules, causing electronic state transitions within the photosensitizer. The excited photosensitizer immediately transfers energy to surrounding molecular oxygen, thereby producing reactive oxygen species (ROS) that are responsible for the lethal cell wall disruption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (PDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Device: Nasal PhotodisinfectionThe procedure is initiated by swabbing the Formulation Applicator, pre-saturated with photosensitizer formulation, inside the patient's nares. The operator then connects the Nasal Light Illuminator (NLI) to the Light Source and inserts the NLIs into the patient's nostrils. The Light Source is turned on, and a 4-minute illumination cycle provides two channels of diffused red light (one for each nostril) to activate the applied formulation. Illumination stops automatically upon completion of the 4-minute cycle. The process is then repeated using two new Formulation Applicators to ensure full disinfection coverage. |
| Sham Comparator: Control | Sham comparator | Device: Sham Comparator: ControlSham comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years of age
- Patient showing a positive test for SARS-CoV-2 with < 26 Ct of an FDA-approved PCR test who is symptomatic or flu-like illness or pneumonia
- Ability to tolerate an 12-minute non-painful nasal light illumination
Key exclusion criteria (3 listed)
- Inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants
- Known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate.
- COVID-19 illness that is moderate or severe in nature.
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 |
|---|---|---|
| Nasal PhotodisinfectionThe procedure is initiated by swabbing the Formulation Applicator, pre-saturated with photosensitizer formulation, inside the patient's nares. The operator then connects the Nasal Light Illuminator (NLI) to the Light Source and inserts the NLIs into the patient's nostrils. The Light Source is turned on, and a 4-minute illumination cycle provides two channels of diffused red light (one for each nostril) to activate the applied formulation. Illumination stops automatically upon completion of the 4-minute cycle. The process is then repeated using two new Formulation Applicators to ensure full disinfection coverage. | Device | Active Intervention |
| Sham Comparator: ControlPatients who are SARS-CoV-2 positive whose PCR levels are followed but no active intervention will be done. Saline will be used in their nose and the light device will be inserted but not turned on. Patient will be wearing light protecting glasses. | Device | Sham Comparator: Control |
Primary outcome
SARS-CoV-2 viral titer reduction
Time frame: Immediately following treatment and on days 3, 7, and 14.
Change from baseline PCR count with testing on days 3, 7 and 14
1 secondary outcome
General safety of nasal photodisinfection
Time frame: 14 days post treatment
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 12 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Josepmaria Argemi, MD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Photodisinfection in people with COVID-19 Respiratory Infection and SARS-CoV-2 Acute Respiratory Disease, run by Ondine Biomedical Inc. at 1 site in Spain.
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 5 inclusion and 3 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 12 Aug 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
SARS-CoV-2 viral titer reduction (time frame: Immediately following treatment and on days 3, 7, and 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2022.