Status:
COMPLETED
Photodynamic Therapy for COVID-19 Prevention
Lead Sponsor:
Ondine Biomedical Inc.
Collaborating Sponsors:
University of Navarra
Conditions:
COVID-19 Respiratory Infection
SARS-CoV-2 Acute Respiratory Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 tim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05184205
Start Date
December 20 2021
End Date
May 30 2022
Last Update
August 12 2022
Active Locations (1)
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1
Clinica Universidad de Navarra
Pamplona, Spain, 31008