Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- HealthQuilt
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- COVID19 symptoms
研究概览
简要总结
Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract.
详细描述
This is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to support an immune function benefit. Up to 100 patients that are COVID-19 positive in the ambulatory setting will be invited to participate. After informed consent is obtained, patients will be in either the Intervention Group (receive extract) or Comparison Group (did not receive extract). A baseline assessment and record review will be conducted to assure eligibility criteria. Patients in the Intervention Group will be given .5 ml (6.25 mg of extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. Patient vital signs (temperature, pulse oximetry, blood pressure) and CDC symptoms / side effects will also be tracked. A dedicated medical oversight team with 24 / 7 access to care will be provided to monitor safety and tolerance. Patients will be followed for 10 days. Baseline antibody, RT-PCR, and live virus will be collected on Day 1, Day 5, and Day 10. A Data Monitoring Committee at the Schull Institute will meet weekly to review data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID 19 positive or close contact of COVID 19 positive
- •No use of cardiac glycosides or other antiarrhythmic medications
排除标准
- •No use of cardiac glycosides or other antiarrhythmic medications
- •No allergy to coconut oil
研究组 & 干预措施
COVID19 Positive: Intervention Group (Receive extract)
These are patients that are COVID19 positive who elect to try the extract.
干预措施: Proprietary extract of Nerium oleander (Other)
COVID19 Positive: Comparison Group (Do NOT receive extract)
These are patients that are COVID19 positive who do NOT elect to try the extract
COVID19 Exposed: Intervention Group (Receive extract)
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.
干预措施: Proprietary extract of Nerium oleander (Other)
COVID19 Exposed: Comparison Group (Do NOT receive extract)
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract.
结局指标
主要结局
COVID19 symptoms
时间窗: Every 6 hours for 10 days
The CDC list of symptoms and "other".
Mortality
时间窗: 10 days from enrollment into the Study, e.g. Day 10
A patient in any arm that dies.
次要结局
- RT-PCR COVID19 Test(Day 1, Day 5, Day 10)
- COVID19 Live Virus(Day 1, Day 5, Day 10)