Melatonin For COVID 19 pre exposure prophylaxis in High Risk population . (MELATONIN IMMUNE BOOST COVID 19 STUDY )
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
- SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group
研究概览
简要总结
Elderly , cardiovascular , obesity are high risk for COVID related severe disease and high mortality and needs to be protected. With advance age immune system go immune senescence and innate immunity is weakened.Decrease in Melatonin has been linked to immunosenesence. Melatonin is safe, inexpensive , proven effect as adjuvant treatment for bacterial and viral infections , anti oxidative and anti inflammatory effect . Melatonin enhances the production of progenitor cells of granulocyte , macrophage and natural killer cells , increases production of IL2,IL6,IL12 and increases helper T cells. It can reverse immunosenescence of old age and immunocompromised states and prevent them from COVID related disease. We study Melatonin oral 3 mg vs placebo in high risk groups for prevention of COVID 19 disease. We study Covid infection rate and other infections and immune response at baseline and 8 weeks in both groups.
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
- 20.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •High groups for COVID 19 related disease Elderly : age > 60 years Diabetes Obesity Heart Failure Immuno supressed patients.
排除标准
- •Chronic Renal Failure Chronic Hepatic Failure Any hospitalisation for past 3 months Any recent vaccination Nutrition supplements Any addiction Chronic infections live Human immunodeficiency disorder , Hepatitis B,C., etc Any autoimmune disease Irregular sleep pattern Primary immunodeficiency states Vitamin deficiency states.
结局指标
主要结局
SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group
时间窗: 8 weeks
次要结局
- Frequency of respiratory tract infections during course of study using the 
Wisconsin Upper Respiratory Symptom Survey
- Change from baseline immune cells and markers after 8 weeks of medications
- Number of participants with treatment-related adverse events(8 weeks)