Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- oxygenation
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.
详细描述
Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 positive
- •Pulmonary compromise requiring oxygen support of approximately 2-6 liters
- •Able to self prone, or support in self-sitting position
排除标准
- •Ventilator management
- •Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
- •Pregnant women
结局指标
主要结局
oxygenation
时间窗: Daily for 4 days
Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
Chest Xray radiographic results
时间窗: 7 Days
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
PSI Score
时间窗: 7 days
The change in pretreatment and post treatment scores will be evaluated
CRP levels
时间窗: 7 days
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
Brescia-COVID Respiratory Severity Scale
时间窗: 7 days
The change in pretreatment and post treatment BCRSS will be evaluated
IL-6 levels
时间窗: First four days of trial
The change in pre treatment levels and 24 hours post final treatment
SMART-COP Score
时间窗: 7 days
The change in pretreatment and post treatment scores will be evaluated
Patient Disposition Post treatment
时间窗: 7 days
ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's
次要结局
未报告次要终点
研究者
Scott Sigman, MD
Principal Investigator
Lowell General Hospital