Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease incidence of intubation by 30% or greater
研究概览
简要总结
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.
详细描述
After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
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 (Outcomes Assessor)
盲法说明
The biostatistician and radiologist will not know which group received HBOT.
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
- •Adult inpatients >18 years old
- •Positive PCR COVID-19 testing
- •CT evidence of interstitial opacity
- •Oxygen saturation <90% on room air
- •pO2 = 55-70.
排除标准
- •Increased oxygen requirements
- •Hemodynamic instability (MAP<65)
- •Bradycardia (HR<50)
- •History of seizure disorder
- •Pneumothorax
- •Hemodialysis
- •Refractory anxiety/claustrophobia
- •Current pregnancy
- •Uncorrectable hypoglycemia
研究组 & 干预措施
Standard of Care group
Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol
HBOT treatment group
Patients will receive hyperbaric oxygen therapy
干预措施: Hyperbaric Oxygen Therapy (Device)
结局指标
主要结局
Decrease incidence of intubation by 30% or greater
时间窗: one month
Compare rates of intubation between treatment and control groups
次要结局
- Decrease renal injury(one month)