Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, COVID-19 Respiratory Infection
Conditions
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.
Interventions
DEVICEUVA Light Emitting Catheter
Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2
DEVICESham Control Catheter
Sham Control Device
Sponsors
Aytu BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomized, Sham Control
Intervention model description
Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in viral load in endotracheal tube aspirates | 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
| Measure | Time frame | Description |
|---|---|---|
| Days to extubation | Day 0 - Day 30 | Days to extubation |
| Development of ventilated associated pneumonia (VAP) | Day 0-Day7 | 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. |
| Days to discharge from hospital | Day 0 - Day 30 | Days to discharge from hospital |
| Mean ordinal scale on day 15 | Day 14 | 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 |
| Mean ordinal scale on day 28 | Day 27 | 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 |
| Changes in Ferritin levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in Ferritin levels (4.63-204.0 ng/mL) day 0-7 |
| Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in interleukin-6 levels (Critical value: ≥ 100 pg/mL) day 0-7 |
| Overall reduction or change of endotracheal bacterial content in upper airway | Day 0-Day 5 | Change in endotracheal bacterial content (determined by culture or PCR methodology) from the ETT aspirate on day 0 to the last day of treatment. |
| Changes in White blood cell levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in White blood cell levels (4.00-11.00 x 1000/UL) day 0-7 |
| Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in Procalcitonin levels (\<0.08 ng/mL) day 0-7 |
| Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in Lymphocyte count (1.00-4.50 x 1000/UL) day 0-7 |
| Changes in D-dimer levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in D-dimer levels (0.00-0.50 µg/mL) day 0-7 |
| Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in Creatine Phosphokinase levels (29-168 U/L) day 0-7 |
| Changes in Troponin levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in Troponin levels (\<0.04 ng/mL) day 0-7 |
| Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure) | Day 0 - Day 5 | Change in viral load for blood serum sample on day 0 through the last day of treatment (Day 0, Day 1, Day 2, etc.) |
| Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care) | Day 0 - Day 7 | Changes in C reactive protein levels (\<5 mg/L) day 0-7 |
Countries
Spain
Outcome results
None listed