Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Aytu BioPharma, Inc.
- Locations
- 2
- Primary Endpoint
- Change in viral load in endotracheal tube aspirates
Study Overview
Brief Summary
A study of intubated critically ill patients infected with SARS-COV-2 to evaluate the safety and treatment effects of ultraviolet-A (UVA) light administered by a novel device via endotracheal tube in a first-in-human study. Study hypothesis was that respiratory SARS-CoV-2 viral burden would significantly decrease following five (5) days of UVA therapy.
Detailed Description
The UV Respiratory Tract Light Therapy Device is intended to emit energy in the UVA region of the spectrum in intubated patients to reduce the viral burden of SARS-CoV-2 (human pathogenic coronavirus (COVID-19)) in intubated patients. The System is to be used in conjunction with the current standard of care measures.
The UV Respiratory Tract Light Therapy Device is intended to be used for 20 minutes per 24-hour period for the endotracheal application for 5 days, in combination with pharmacological and/or physical measures to optimize the therapeutic outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Randomized, Sham Control
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 years of age
- •Confirmed positive test result for SARS-CoV-2 within 14d
- •Mechanically ventilated (first intubation since positive SARS-CoV-2 test)
- •Endotracheal tube inner diameter at least 7.5 mm
Exclusion Criteria
- •Unable to provide informed consent (or surrogate)
- •Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.
- •Pregnant women. While not an exclusion criterion, special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.
Arms & Interventions
UVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.
Intervention: UVA Light Emitting Catheter (Device)
Sham Control Device
Sham Control Device
Intervention: Sham Control Catheter (Device)
Outcomes
Primary Outcomes
Change in viral load in endotracheal tube aspirates
Time Frame: Day 0-Day 5
Difference in change in viral load from the endotracheal tube (ETT) aspirates on day 0 to the last day of treatment between treated and untreated subjects.
Secondary Outcomes
- Overall reduction or change of endotracheal bacterial content in upper airway(Day 0-Day 5)
- Mean ordinal scale on day 15(Day 14)
- Days to extubation(Day 0 - Day 30)
- Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Troponin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)(Day 0 - Day 5)
- Development of ventilated associated pneumonia (VAP)(Day 0-Day7)
- Days to discharge from hospital(Day 0 - Day 30)
- Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Mean ordinal scale on day 28(Day 27)