Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Cured Patients
研究概览
简要总结
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
详细描述
Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.
The comparison group was a historical control population and data collected from the current study were compared to that historical control population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.
- •Understands and agrees to comply with planned study procedures.
排除标准
- •Patients with hypersensitivity or severe adverse effects to Ivermectin
- •Renal impairment
- •Hepatic impairment.
- •Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
- •Breast feeding.
- •Patient with covid 19 positive and mild no pneumonia
- •Children under the age of five or those who weigh less than 15 kilograms
研究组 & 干预措施
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily
干预措施: Ivermectin (IVM) (Drug)
结局指标
主要结局
Number of Cured Patients
时间窗: 4 weeks
Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
次要结局
- Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group(4 week)
研究者
Faiq Gorial
Professor and consultant rheumatologist
University of Baghdad