Double Blind Randomised Placebo Controlled Trial for Evaluation of Efficacy and Safety of Ingavirin® for Post-exposure Profilaxis During Rise in the Incidence of Influenza and Other Acute Respiratory Viral Infections in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
研究概览
简要总结
The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections
详细描述
The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.
The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.
Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.
Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.
The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season
- •First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours
- •Signed Informed Contest to participate in the study
- •Contraception throughout the study
排除标准
- •Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion
- •Anti-virals intake, other then investigational drug, throughout the study
- •Vaccination for Influenza less than 1 year before inclusion
- •Pregnant or lactating
研究组 & 干预措施
Ingavirin
Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days
干预措施: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) (Drug)
Placebo
Placebo oral capsule, once daily for 7 days
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
时间窗: Through study completion, an average of 37 days
To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)\*100% then divided by incidence in placebo group.
次要结局
- Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri(Through study completion, an average of 37 days)