Observational study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical College, Ujjain, India
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a modified ordinal scale (as recommended by the WHO R&D Blueprint Group)
研究概览
简要总结
This study titled - International study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical college, Ujjain, Madhya Pradesh is a single arm, open label, observational study. The objective of this single centre study is to evaluate safety and efficacy of Inj Sepsivac, (Mycobacterium w repurposed drug for severe gram negative sepsis) in patients of Covid-19. Sample size is 50 patients with inclusion criteria of age between 18 – 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay, and any one or more of the following: a) either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support, b) creatinine clearance above 30 ml per minute, c) serum levels of ALT and AST less than five times the upper limit of the normal range and d) requirement of vasopressor. Patients will be recruited till maximum of 6 months. The follow up of patient will be till 28 days with following schedule: daily till 7 days, then on 14 and 28 days. The follow-up will include clinical follow up and certain laboratory parameters like liver functions and renal functions.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age of 18 – 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay, and any one or more of the following
- •Either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support
- •Creatinine clearance above 30 ml per minute
- •Serum levels of ALT and AST less than five times the upper limit of the normal range
- •Requirement of vasopressor.
排除标准
- •1.Pregnant or nursing female.
- •2.Patient previously enrolled into similar study.
- •3.Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- •4.Patients not likely to complete the trial as per judgment of the investigator.
结局指标
主要结局
Clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a modified ordinal scale (as recommended by the WHO R&D Blueprint Group)
时间窗: 28 days
Conversion of Covid19 status to negative
时间窗: 28 days
次要结局
- 1. Overall safety of the study drug(2. Duration of hospitalization)