Respiratory COVID-19: A Randomized, Sham-Controlled Study

Aytu BioPharma, Inc.

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

COVID-19 Pneumonia Acute Respiratory Distress Syndrome COVID-19 Acute Respiratory Distress Syndrome COVID-19 Respiratory Infection

Interventions

UVA Light Emitting CatheterDEVICE

Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2

Sham Control CatheterDEVICE

Sham Control Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients over 18 years of age 2. Confirmed positive test result for SARS-CoV-2 within 14d 3. Mechanically ventilated (first intubation since positive SARS-CoV-2 test) 4. Endotracheal tube inner diameter at least 7.5 mm Exclusion Criteria: 1. Unable to provide informed consent (or surrogate) 2. Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials. 3. 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.

Locations (2)

Hospital Clinic of Barcelona

Barcelona, Catalan, Spain

Vall d'Hebron University Hospital

Barcelona, Catalan, Spain

Outcomes

Primary Outcomes

Change in viral load in endotracheal tube aspirates

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.

Time frame: Day 0-Day 5

Secondary Outcomes

Overall reduction or change of endotracheal bacterial content in upper airway

Change in endotracheal bacterial content (determined by culture or PCR methodology) from the ETT aspirate on day 0 to the last day of treatment.

Time frame: Day 0-Day 5

Days to extubation

Time frame: Day 0 - Day 30

Development of ventilated associated pneumonia (VAP)

Percentage of development of VAP in between day 0 to day 7. VAP is defined by new or progressive pulmonary infiltrates on imaging along with clinical suspicion by the managing team (e.g. fever, leukocytosis, increased procalcitonin) warranting initiation or change in antibiotic therapy.

Time frame: Day 0-Day7

Days to discharge from hospital

Time frame: Day 0 - Day 30

Mean ordinal scale on day 15

1. Death 2. Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home-oxygen; 8. Not hospitalized, no limitations on activities

Data from ClinicalTrials.gov

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