跳至主要内容
临床试验/NCT04524715
NCT04524715撤回不适用

Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients

Ward Photonics LLC2 个研究点 分布在 1 个国家开始时间: 2021年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Inflammation of the lungs - CRP

研究概览

简要总结

To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.

详细描述

This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19.

Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.

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
Single (Participant)

盲法说明

All participants undergo LLLT treatment; however, the active group receives LED light in the red and IR range while the placebo group is told they are receiving IR light not visible to naked eye. All participants continue receiving standard treatments for COVID19 symptoms.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is diagnosed with COVID-
  • Study participant is 18 years of age or older.
  • Patient exhibiting moderate-to-acute respiratory distress.

排除标准

  • Photosensitive condition or medication.
  • Active chemotherapy treatment or other cancer treatment.
  • Autoimmune Disorder.
  • Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
  • Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.

结局指标

主要结局

Inflammation of the lungs - CRP

时间窗: 10 days

Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test

Inflammation of the lungs - IL6

时间窗: 10 days

Change in inflammation of the lungs as measured by IL-6 Levels

Inflammation of the lungs - O2

时间窗: 10 days

Change in inflammation of the lungs as measured by O2 saturation levels

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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