CTRI/2020/07/026820尚未招募4 期
Curcumin for COVID-19 Pre Exposure Prophylaxis: A Randomised Controlled Trail
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Rohit Walia
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. SARS-CoV 2 infection rate Using RTPCR
研究概览
简要总结
Curcumin has been proven to have anti viral , anti bacterial and anti inflammatory properties and immunomodulator. We plan to a randomised controlled trail to study curcumin as pre exposure prophylaxis in healthcare workers and high risk groups and look for Covid infection rates over a period of 12 weeks and look for COVID positivity rates over a period of 12 weeks between cur cumin vs. placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •People at risk of SARS-CoV 2 infection ( healthcare professionals , attendants of COVID patients , non COVID patients admitted in hospitals or his risk groups like elderly , cardiovascular patients , diabetes , obesity ) Not having a previous COVID19 diagnosis Not having experienced COVID19 symptoms since 30 th Jan
- •Not having taken any pre-exposure prophylaxis ( HCQ , any other medication or Ayurvedic preparation or food supplement ) Having a negative SARS-CoV 2 test before randomisation.
排除标准
- •Any chronic infection Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis Known history of hypersensitivity to the study drug or any of its components Immune suppressant drugs Recent vaccination within 2 month Pregnancy Primary Immunodeficiency states • Anemia Leukopenia Thrombocytopenia Co morbidities precluding survival required for duration of study follow up.
结局指标
主要结局
1. SARS-CoV 2 infection rate Using RTPCR
时间窗: 12 weeks
次要结局
- Frequency of respiratory tract infections during course of study using the Wisconsin Upper Respiratory Symptom Survey
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.(12 weeks)
研究者
研究点 (1)
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