Photodynamic Therapy for COVID-19 Prevention

NCT05184205 | Completed

• 1 other identifier: SARS_PDT01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection; SARS-CoV-2 Acute Respiratory Disease

Keywords

SARS-CoV-2; antimicrobial photodynamic therapy (aPDT); COVID-19; viral load; Nasal decolonization

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 viral titer reduction

  Change from baseline PCR count with testing on days 3, 7 and 14

  Immediately following treatment and on days 3, 7, and 14.

Secondary Outcomes (1)

• General safety of nasal photodisinfection

  14 days post treatment

Study Arms (2)

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.

Device: Nasal Photodisinfection

Sham Comparator: Control

SHAM COMPARATOR

Sham comparator

Device: Sham Comparator: Control

Interventions

Nasal Photodisinfection DEVICE

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.

Active Intervention

Sham Comparator: Control DEVICE

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.

Sham Comparator: Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondine Biomedical Inc.: lead
• University of Navarra: collaborator

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Josepmaria Argemi, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: December 20, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)