The Clinical Trial of Application of Methylene Blue Vial for Treatment of Covid-19 Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients remaining free of need for mechanical ventilation in both groups
研究概览
简要总结
The severe acute respiratory syndrome caused by COVID-19 is now a global catastrophic event. Currently there is no approved drug or vaccine for the disease. Methylene blue (MB, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. Leucomethylene Blue (reduced form of MB, colorless) may be applied for the treatment of COVID-19 according to the scientific evidences.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed case of Covid-19 (by RT-PCR, HRCT)
- •Admission to Intensive Care Unit
- •Need for intubation and mechanical ventilation (PaO2/FiO2 < 100-200)
- •Written informed consent
排除标准
- •Pregnancy and breastfeeding
- •History of G6PDH deficiency
- •Preadmission anticoagulation
- •Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- •Medical records of cirrhosis
- •Active chronic hepatitis
- •Severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit
- •Patients with history of allergic reaction or significant sensitivity to Methylene blue
- •Treatment with immunosuppressive agents
- •Use of other investigational drugs in the moment of inclusion
研究组 & 干预措施
Intervention group
Covid-19 patients treated with mixture of MCN (Methylene blue, vitamin C, N-acetyl cysteine).
干预措施: MCN (Methylene blue, vitamin C, N-acetyl cysteine) (Drug)
结局指标
主要结局
Proportion of patients remaining free of need for mechanical ventilation in both groups
时间窗: Day 7
All patient will be assess for changes in disease severity.
次要结局
- C-reactive proteins(3-5 Days)
- WBC Count(3-5 Days)
- Mortality rate in both groups(Day 28)
- Improvement in Pa02/Fi02 ratio in both groups(Day 2)
- Duration of hospital stay in both group.(Day 28)
- Duration of Intensive Care Unit stay in both groups(Day 28)
- Days free of dialysis in both groups(Day 28)
研究者
Daryoush Hamidi Alamdari
Associate professor
Mashhad University of Medical Sciences