Clinical trial NCT05166915: Respiratory COVID-19: A Randomized, Sham-Controlled Study
Official title: Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19 Pneumonia
Acute Respiratory Distress Syndrome
COVID-19 Acute Respiratory Distress Syndrome
COVID-19 Respiratory Infection
Lead sponsor: Aytu BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in viral load in endotracheal tube aspirates
timeFrame: Day 0-Day 5
Secondary outcomes:
measure: Overall reduction or change of endotracheal bacterial content in upper airway
timeFrame: Day 0-Day 5
measure: Days to extubation
timeFrame: Day 0 - Day 30
measure: Development of ventilated associated pneumonia (VAP)
timeFrame: Day 0-Day7
measure: Days to discharge from hospital
timeFrame: Day 0 - Day 30
measure: Mean ordinal scale on day 15
timeFrame: Day 14
measure: Mean ordinal scale on day 28
timeFrame: Day 27
measure: Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Changes in Troponin levels (Exploratory Measure those drawn for clinical care)
timeFrame: Day 0 - Day 7
measure: Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)
timeFrame: Day 0 - Day 5
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
state: Catalan
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
state: Catalan
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antoni Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: