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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05166915
• Other study ID #: UVL-0001
• Status: Withdrawn
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Aytu BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• COVID-19 Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Infections
• Syndrome

Intervention

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 Control Catheter
Sham Control Device

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona	Catalan
Spain	Vall d'Hebron University Hospital	Barcelona	Catalan

Sponsors (1)

Lead Sponsor	Collaborator
Aytu BioPharma, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Days to extubation	Days to extubation	Day 0 - Day 30
Secondary	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
Secondary	Days to discharge from hospital	Days to discharge from hospital	Day 0 - Day 30
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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