A Multi-Center, Open label, Post approval for restricted use under emergency situation study to assess the Safety and Efficacy of Remdesivir in moderate to severe SARS CoV2 infection (COVID 19) in Indian patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- 4.Mortality rate at Day 28
研究概览
简要总结
COVID-19 is a respiratory illness that has led to a pandemic affecting more than 200 countries in the world. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses.
Remdesivir is authorized for use for treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and moderate to severe disease Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
As per the definition of MoHFW guidelines:
Moderate disease is defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
Severe disease is defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age -18 years and above (no upper age limit) 2.Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection.
- •3.Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
- •4.Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.
排除标准
- •Exclusion Criteria: 1.Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
- •2.Inability of subject or legally authorized representative to provide written informed consent.
- •3.Patients with <40 kg body weight 4.eGFR less than 30 mL per minute 5.Pregnant or nursing women 6.Patients with ALT/AST ≥ 5 times the upper limit of normal at baseline 7.Evidence of multiorgan failure 8.Mechanically ventilated (including Veno-Venous ECMO) ≥ 5 days, or any duration of Veno-Arterial ECMO 9.Exposed to other investigational drugs within 30 day of first administration of Remdesivir.
- •10.Unsuitable for the study in the opinion of the Investigator.
结局指标
主要结局
4.Mortality rate at Day 28
时间窗: 28 days of follow up
2.Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
时间窗: 28 days of follow up
3.Percentage of subjects with improvement of at least 2 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28]
时间窗: 28 days of follow up
1.Time to recovery [ Time Frame: Day 1 through Day 28]
时间窗: 28 days of follow up
次要结局
- 1.Percentage of subjects with improvement of at least 1 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28](2.Proportion of subjects with viral clearance (SARS CoV-2 negativity) at Day 7 and Day 14 or at hospital discharge (whichever is earlier))