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

Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: UVA Light Emitting Catheter; Device: Sham Control Catheter

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalan
    • Barcelona, Catalan, Spain, 08036
      • Hospital Clinic of Barcelona
    • Barcelona, Catalan, Spain, 08036
      • Vall d'Hebron University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UVA Light Emitting Catheter; Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2.	Device: UVA Light Emitting Catheter; Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
Sham Comparator: Sham Control Device	Device: Sham Control Catheter; Sham Control Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0-Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0-Day 5
Days to extubation	Days to extubation	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.	Day 0-Day7
Days to discharge from hospital	Days to discharge from hospital	Day 0 - Day 30
Mean ordinal scale on day 15	Death; Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen;; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);; Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;; Not hospitalized, limitation on activities and/or requiring home-oxygen;; Not hospitalized, no limitations on activities	Day 14
Mean ordinal scale on day 28	Death; Hospitalized, on invasive mechanical ventilation with additional organ support, ECMO, pressors, RRT; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen;; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);; Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;; Not hospitalized, limitation on activities and/or requiring home-oxygen;; Not hospitalized, no limitations on activities	Day 27
Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)	Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7	Day 0 - Day 7
Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)	Changes in interleukin-6 levels (Critical value: ≥ 100 pg/mL) day 0-7	Day 0 - Day 7
Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)	Changes in C reactive protein levels (<5 mg/L) day 0-7	Day 0 - Day 7
Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)	Changes in White blood cell levels (4.00-11.00 x 1000/UL) day 0-7	Day 0 - Day 7
Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)	Changes in Procalcitonin levels (<0.08 ng/mL) day 0-7	Day 0 - Day 7
Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)	Changes in Lymphocyte count (1.00-4.50 x 1000/UL) day 0-7	Day 0 - Day 7
Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)	Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7	Day 0 - Day 7
Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)	Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7	Day 0 - Day 7
Changes in Troponin levels (Exploratory Measure those drawn for clinical care)	Changes in Troponin levels (<0.04 ng/mL) day 0-7	Day 0 - Day 7
Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)	Change in viral load for blood serum sample on day 0 through the last day of treatment (Day 0, Day 1, Day 2, etc.)	Day 0 - Day 5

Collaborators and Investigators

• Sponsor: Aytu BioPharma, Inc.
• Investigators: Principal Investigator: Antoni Torres, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Tract Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: UVL-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes