Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
详细描述
Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 86 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 patients at any stage of this disease
排除标准
- •Patients of allergic history to Ivermectin or to doxycyline
研究组 & 干预措施
Ivermectin-Doxycycline
Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
干预措施: Ivermectin and Doxycyline (Drug)
Ivermectin-Doxycycline
Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
干预措施: Standard of care (Drug)
Control
Control group: The patients in this group received only standard care which included all or some of the following, according to the clinical condition of each patient.
干预措施: Standard of care (Drug)
结局指标
主要结局
Mortality rate
时间窗: Up to 8 weeks
The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
Rate of progression disease
时间窗: up to 8 weeks
rate of patients under treatment who undergo progression of disease to a more advanced stage
次要结局
- Time to recovery(Up to 8 weeks)
研究者
Ahmed Sahib Abdulamir
M.B.Ch.,B., Phd Virology, Professor
Alkarkh Health Directorate-Baghdad