Randomised Double Blind Placebo Controlled Multicenter Study for Evaluation of Clinical Efficacy and Safety of Ingavirin 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 9
- 主要终点
- Time to resolution of fever
研究概览
简要总结
The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.
详细描述
Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:
- •Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
- •Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
- •Laboratory confirmation of viral origin of the disease
- •Uncomplicated influenza and other acute respiratory viral infections
- •Interval between onset of symptoms and enrollment to the study not more than 48 hours
- •Have read, understood and signed an informed consent form
排除标准
- •Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
- •Pregnancy and Breastfeeding
- •Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)
- •Cancer, HIV infection, tuberculosis, including those in history
- •History of alcohol and drug abuse
研究组 & 干预措施
Ingavirin
Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
干预措施: Ingavirin (Drug)
Placebo
Placebo capsule identical in appearance to Ingavirin capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of fever
时间窗: 7 ± 1 days
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).
次要结局
- Time to resolution / alleviation of intoxication symptoms(7 ± 1 days)
- Time to resolution / alleviation of catarrhal symptoms(7 ± 1 days)