Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug "Efesovir" (Oral Solution) for Coronavirus Infection (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clinical Response Rate
研究概览
简要总结
Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug "Remdesivir" in the treatment of patients hospitalized with COVID-19.
The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10% to 30% higher than of "Remdesivir".
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
- None
盲法说明
no masking, open label
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin
- •the duration of the COVID-19 disease is no more than 10 days
- •informed concent to participate in clinical trials
- •informed concent to to use reliable contraceptive methods while participating in a clinical trial
排除标准
- •age less than 18 years old and over 59 years old
- •pregnancy or breastfeeding
- •hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines
- •hypersensitivity to Remdesivir or its components
- •impaired consciousness, causing the impossibility of oral administration
- •conditions or circumstances that, in the opinion of the investigator, may affect the patient's safety or the quality of the results obtained
- •participation in another clinical trial, including in the period up to 2 months before this study
- •signs of multiple organ failure
- •alanine aminotransferase (ALT), aspartate aminotransferase (AST) is 5 or more times higher than normal
- •thrombocytopenia below 100 * 10^9/ l
- •decrease in glomerular filtration rate (GFR) less than 30 ml / min by 1.73 m2
- •chronic heart failure with reduced ejection fraction
- •liver failure
- •coagulopathy
- •mechanical ventilation for 48 hours or more
- •extracorporeal membrane oxygenation (ECMO)
- •disseminated intravascular coagulation
研究组 & 干预措施
Efesovir
The patients of experimental arm take study drug Efesovir twice a day as an antiviral therapy in dose 0.125 ml / kg. Daily dose of Efesovir: 0.250 ml / kg. Duration of treatment is 5 - 10 days, depending on the severity of the disease.
干预措施: Efesovir (Drug)
Remdesivir
The patients are treated with the antiviral drug "Remdesivir" in dose 200 mg intravenously on the 1st day, then by 100 mg intravenously daily for 5 - 10 days, depending on the severity of the disease.
干预措施: Efesovir (Drug)
结局指标
主要结局
Clinical Response Rate
时间窗: 21 days
Clinical Response Rate is calculated as the number of trial subjects with effective treatment over the total number of subjects multiplied by 100. It is calculated in each study group. Measured in percents. The outcome is estimated among randomized subjects completed clinical study with the protocol requirements (per protocol population (PPP)). Clinical response is evaluated as effective treatment if: all signs and symptoms of COVID19 are resolved or improved with no worsening or appearance of new signs and symptoms; there is no requirement for additional antiviral of antibacterial therapy; chest roentgenograms (CT scans) are improved. The outcome is assessed in day 21 from the start of Study Drug treatment (visits 13).
次要结局
- Early Clinical Response Rate(72 hours (3 days) of study drug treatment)
- Survival rate(21 days)
- Percentage of clinically stable patients(72 hours (3 days) of study drug treatment)
- Thyroid gland function(Day 21)
- Early Clinical Response Rate in pneumonia(72 hours (3 days) of study drug treatment)
- Adverse Events (AE)(up to 21 days)
- Clinical Status Change(7 days)