A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
研究概览
简要总结
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
详细描述
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
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
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
干预措施: Hydroxychloroquine (Drug)
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
干预措施: Azithromycin (Drug)
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
干预措施: Vitamin C (Dietary Supplement)
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
干预措施: Vitamin D (Dietary Supplement)
Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
干预措施: Zinc (Dietary Supplement)
Placebo
Patients will be treated with placebo.
干预措施: Vitamin C (Dietary Supplement)
Placebo
Patients will be treated with placebo.
干预措施: Vitamin D (Dietary Supplement)
Placebo
Patients will be treated with placebo.
干预措施: Zinc (Dietary Supplement)
结局指标
主要结局
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
时间窗: 12 weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or Progression of Symptomatic Days
时间窗: 12 weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy
时间窗: 12 weeks
Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse
时间窗: 12 weeks
Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
时间窗: 12 weeks
Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG
时间窗: 12 weeks
EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy
时间窗: 12 weeks
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
次要结局
未报告次要终点