Study to assess the efficacy of Ivermectin as prophylaxis of COVID 19 among health care workers and COVID 19 contacts in Ujjain, India
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Effect of Ivermectin as prophylaxis of virus
研究概览
简要总结
This aims of this study is to validate the antiviruseffectiveness of Ivermectin as prophylaxis 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.
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
- 6.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Following are eligible to participate after giving written consent/assent.
- •Healthy health care workers
- •Contact of COVID 19.
排除标准
- •Un healthy
- •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 as prophylaxis of virus
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
OR
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
Outcome indicators are :
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
1. Resolution of sign and symptoms of COVID 19
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
2. Negative RTPCR done 48 hours after Ivermectin dose
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay.
时间窗: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
次要结局
- Overall safety of the study drug(The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form.)