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Indefinite hold by Company.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVA Light Emitting Catheter | Experimental | Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2. |
|
| Sham Control Device | Sham Comparator | Sham Control Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVA Light Emitting Catheter | Device | Experimental Device intended to eliminate microorganisms using UV-A light, thereby reducing the viral burden of SARS-CoV-2 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Torres, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | Catalan | 08036 | Spain | ||
| Vall d'Hebron University Hospital |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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Subjects will be randomized 1:1 to receive treatment with the functional UVA light catheter or the sham control device.
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Randomized, Sham Control
| Sham Control Catheter | Device | Sham Control Device |
|
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 |
| Day 14 |
| Mean ordinal scale on day 28 |
| 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 |
| Barcelona |
| Catalan |
| 08036 |
| Spain |