Respiratory Application of a Novel Ultraviolet Light Delivery Device for Patients Infected With COVID-19: A Randomized, Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Change in viral load in endotracheal tube aspirates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomized, Sham Control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Confirmed positive test result for SARS-CoV-2 within 14d
- •Mechanically ventilated (first intubation since positive SARS-CoV-2 test)
- •Endotracheal tube inner diameter at least 7.5 mm
排除标准
- •Unable to provide informed consent (or surrogate)
- •Enrolled in a therapeutic clinical trial for COVID-19 that does not allow recruitment in other trials.
- •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.
结局指标
主要结局
Change in viral load in endotracheal tube aspirates
时间窗: 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.
次要结局
- Change in Interleukin-6 (IL-6) levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in C reactive protein levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in White blood cell levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Procalcitonin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Lymphocyte counts (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in D-dimer levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Troponin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Overall reduction or change of endotracheal bacterial content in upper airway(Day 0-Day 5)
- Mean ordinal scale on day 15(Day 14)
- Overall reduction or change of SARS-CoV-2 serum viral load (Exploratory Measure)(Day 0 - Day 5)
- Days to extubation(Day 0 - Day 30)
- Development of ventilated associated pneumonia (VAP)(Day 0-Day7)
- Days to discharge from hospital(Day 0 - Day 30)
- Changes in Ferritin levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Changes in Creatine Phosphokinase levels (Exploratory Measure those drawn for clinical care)(Day 0 - Day 7)
- Mean ordinal scale on day 28(Day 27)