Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- In-hospital and 28-day mortality
研究概览
简要总结
This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.
详细描述
This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.
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 (Participant)
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
- •Aged ≥18 years
- •Laboratory-confirmed SARS-CoV- 2 infection
- •Hospitalized patients
- •need reservoir mask for oxygen support
- •need HFNC for oxygen support
排除标准
- •Mechanical ventilations for oxygen support
- •Inability to take oral medications
- •Pregnancy or breastfeeding
研究组 & 干预措施
INTERVENTION ARM
干预措施: Ivermectin,ribavirin ,nitazoxanide and zinc (Drug)
结局指标
主要结局
In-hospital and 28-day mortality
时间窗: 28 day
Stabilization of oxygen
时间窗: 28 days
at room air more than 90%
次要结局
- Time to clinical improvement(28 day)
- Negative conversion of SARS-CoV- 2 by Day 28(28 day)
研究者
Hatem Elalfy
professor
Mansoura University