Photodynamic Therapy for COVID-19 Prevention

Sponsor

Ondine Biomedical Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05184205

Collaborator

University of Navarra (Other)

100

Enrollment

Location

Arms

5.3

Actual Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection SARS-CoV-2 Acute Respiratory Disease	Device: Nasal Photodisinfection Device: Sham Comparator: Control	N/A

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

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Masking Description:

The placebo control arm will include the application of saline isotonic solution and the introduction of the PDT device with no powering on. Due to the characteristics of the device, and the need for the investigator to deliberately not switching it on, it is clear that there cannot be a blind scheme in this trial.

Primary Purpose:

Prevention

Official Title:

Photodynamic Therapy for SARS-CoV-2 Viral Reduction in the Upper Airway in PCR-positive Asymptomatic Individuals.

Actual Study Start Date :

Dec 20, 2021

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Intervention 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.	Device: Nasal Photodisinfection 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: Sham Comparator: Control Sham comparator	Device: Sham Comparator: Control 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.

Arm

Intervention/Treatment

Experimental: Active Intervention

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.

Device: Nasal Photodisinfection

Sham Comparator: Sham Comparator: Control

Sham comparator

Device: Sham Comparator: Control

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.

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 viral titer reduction [Immediately following treatment and on days 3, 7, and 14.]
Change from baseline PCR count with testing on days 3, 7 and 14

Secondary Outcome Measures

General safety of nasal photodisinfection [14 days post treatment]
Observation for any adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.