Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Melatonin
研究概览
简要总结
The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
- •Oxygen saturation drop below 93%
- •Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the patient's previous normal systolic blood pressure
- •Dry cough
- •Positive PCR for COVID-19
- •Laboratory indices include CRP and ESR indicating COVID-19
排除标准
- •Patient dissatisfaction
- •Existence of drug interactions
- •Lack of proper conditions for receiving medication
研究组 & 干预措施
Test Group
Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
干预措施: Melatonin (Drug)
Test Group
Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
干预措施: The usual treatment (Drug)
Control Group
Participants in this group will receive the usual treatment of COVID-19
干预措施: The usual treatment (Drug)
结局指标
主要结局
Melatonin
时间窗: up to 10 days
Immune system modulator. The amount of it is determined by laboratory methods
次要结局
- Inflammatory route(up to 10 days)
- Inflammatory cytokines(up to 10 days)
- Oxygen saturation of the blood(up to 10 days)
- ESR(up to 10 days)
- Radiological Treatment Response(up to 10 days)
- C-reactive protein (CRP)(up to 10 days)
- Cough(up to 10 days)
研究者
Mohammad Sadegh Bagheri Baghdasht
Principal Investigator
Baqiyatallah Medical Sciences University
