CTRI/2021/04/033142尚未招募不适用
An Observational pilot study to determine the effectiveness of Methylene Blue treatment in Covid 19 patients
DR SMITHA K S1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To observe the effects of Methylene blue treatment in Covid 19 patients.
研究概览
简要总结
As Covid pandemic has created a havoc through out the world with alarming morbidity and mortality. There are many treatment modalities at present for covid, one such being treatment with methylene blue. As it is seen that in covid patients there will be hypoxia due to methhemoglobinemia. Methylene blue is FDA approved drug for the same.Hence , the main purpose of this study is to observe the effects of its treatment in covid patients. Also, this pilot study aims to help in generating a protocol for further randomised controlled studies in treatment of covid patients with Methylene blue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed case of Covid 19 (RT-PCR) 2) Admission to Intensive care unit 3) Sex-Males and Females 4) Age- 18 to 90 years old.
- •Need for Oxygen support ( HFNC, NIV) 6) Respiratory rate (RR) between 20 to 30 7) SpO2 between ≤90 to 94 on room air.
- •PaO2/FiO2 <200-300 9) Written informed consent.
排除标准
- •Pregnancy and breastfeeding 2) History of G6PD deficiency 3) Severe renal insufficiency (GFR<30ml/min/1.73m2) 4) Medical records of Cirrhosis 5) Active or Chronic Hepatitis 6) History of allergy to Methylene blue 7) Patients on immunosuppressive agents.
- •Patients exposed to aniline dyes and Dapsone.
结局指标
主要结局
To observe the effects of Methylene blue treatment in Covid 19 patients.
时间窗: 7 days
次要结局
- To record side effects of Methylene blue treatment in covid 19 patients(30 days)
研究者
研究点 (1)
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