Interventional study to assess the efficacy of Ivermectin with standard of care treatment versus standard of care in patients of COVID-19 at R D Gardi Medical College, Ujjain, India
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect of Ivermectin on eradication of virus.
研究概览
简要总结
The aim of this study is to validate the antiviruseffectiveness of Ivermectin on coronavirus i.e COVID 19 and study itseffectiveness in combating COVID 19 pandemics.
At present, there are no specific treatments forCOVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to havebroad-spectrum anti-viral activity in vitro, is an inhibitor of the causativevirus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours postinfection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNAat 48 h. Ivermectin is a CDSCO approved drug. However, it requires furtherinvestigation for possible benefits COVID-19 patients and further eradicationof COVID-19 virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (age ≥18 years to ≤75 years)
- •Laboratory-confirmed SARS-CoV-2 infection and, in the view of the responsible doctor, no contra-indication to any of the study treatments
- •Hospitalized at R D Gardi Medical College, Ujjain Madhya Pradesh.
排除标准
- •Anticipated transfer to another hospital, within 72 hours, which is not a study site
- •Known allergy to study medication or its components (non-medicinal ingredients)
- •Known HIV infection.
结局指标
主要结局
Effect of Ivermectin on eradication of virus.
时间窗: 3 months
Test for virus at 1, 3 and 5 days from beginning of trial drug started for the patient in the hospital
时间窗: 3 months
次要结局
- 1. Overall safety of the study drug(2. Duration of hospitalization)