Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of individuals who develop COVID-19 symptoms
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have one or more of the following:
- •confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
- •continued close contact with an individual with suspected SARS-CoV-2 infection
- •at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.
排除标准
- •Patients must not have any uncontrolled disease such as:
- •cardiovascular disease
- •hepatic disease
- •renal disease
- •metabolic disease
- •other diseases or insufficiencies
研究组 & 干预措施
Regimen
0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin
干预措施: Hydroxychloroquine (Drug)
Regimen
0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin
干预措施: Vitamins and Minerals (Dietary Supplement)
Regimen
0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin
干预措施: Azithromycin (Drug)
结局指标
主要结局
Percentage of individuals who develop COVID-19 symptoms
时间窗: 6 months from study start
The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.
次要结局
未报告次要终点
研究者
Philip DeFina, PhD
Chief Executive Officer
International Brain Research Foundation