Respiratory COVID-19: A Randomized, Sham-Controlled Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 Sham Control Device |
Device: Sham Control Catheter
Sham Control Device
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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]
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
- Mean ordinal scale on day 28 [Day 27]
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
- 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
- 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
- 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.)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years of age
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Confirmed positive test result for SARS-CoV-2 within 14d
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Mechanically ventilated (first intubation since positive SARS-CoV-2 test)
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Endotracheal tube inner diameter at least 7.5 mm
Exclusion Criteria:
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Unable to provide informed consent (or surrogate)
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Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinic of Barcelona | Barcelona | Catalan | Spain | 08036 |
| 2 | Vall d'Hebron University Hospital | Barcelona | Catalan | Spain | 08036 |
Sponsors and Collaborators
- Aytu BioPharma, Inc.
Investigators
- Principal Investigator: Antoni Torres, MD, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UVL-0001