A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
研究概览
简要总结
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
详细描述
In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study
- •Male or female patients 18 years of age or older that are considered to be high-risk individuals.
- •a. High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
- •Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
排除标准
- •Refusal to provide informed consent
- •Any previous positive test for COVID-19 by RT-PCR
- •Symptomatic for COVID-19
- •Diarrhea prior to the start of treatment
- •Type I or II diabetes
- •Atherosclerotic Coronary Artery Disease
- •Any contraindication for treatment with hydroxychloroquine including:
- •Hypoglycemia
- •G6PD deficiency
- •Neutropenia
- •Myasthenia Gravis
- •Skeletal muscle disorder
- •Maculopathy
- •Changes in the visual field
- •Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal
- •Any contraindicated medications found in Appendix 2
- •Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
- •Vaccination for SARS-CoV-2
研究组 & 干预措施
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
干预措施: Hydroxychloroquine (Drug)
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
干预措施: Vitamin C (Dietary Supplement)
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
干预措施: Vitamin D (Dietary Supplement)
Medical Workers
Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
干预措施: Zinc (Dietary Supplement)
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
干预措施: Vitamin C (Dietary Supplement)
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
干预措施: Vitamin D (Dietary Supplement)
Placebo
Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
干预措施: Zinc (Dietary Supplement)
结局指标
主要结局
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
时间窗: 24 weeks
To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Prevention of COVID-19 symptoms as recorded in a daily diary
时间窗: 24 weeks
Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
次要结局
未报告次要终点