NCT02644018已完成3 期
Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 13
- 主要终点
- Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature
研究概览
简要总结
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.
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)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study.
- •Male and female patients aged 3-
- •Patients with moderate course of influenza or other acute respiratory viral infections.
- •Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:
- •Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
- •Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion.
- •Established diagnosis J06.9, J10, J11, in accordance with ICD-
- •Uncomplicated course of influenza and other ARVI.
- •Interval between onset of symptoms and enrollment to the study of not more than 36 hours.
排除标准
- •Complicated course of influenza and other acute respiratory viral infections.
- •Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 14 days prior to the screening visit.
- •Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes.
- •Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs.
- •Infectious diseases within the last week prior to enrollment.
- •"RRI children" (incidence of ARVI within the last 12 months is 6 times or more).
- •Asthma history.
- •History of increased seizure activity.
- •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 and also make it impossible to conduct a clinical study in the patient).
- •Cancer, HIV infection, tuberculosis, including those in history.
- •Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of Ingavirin product.
- •Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase.
- •Participation of the patient in any other clinical trial within the last 90 days prior to enrollment.
研究组 & 干预措施
Ingavirin
Experimental
Ingavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
干预措施: Imidazolyl ethanamide pentandioic acid (Drug)
Placebo
Placebo Comparator
Placebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
干预措施: placebo (Drug)
结局指标
主要结局
Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature
时间窗: 5 days
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
次要结局
- The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment(5 days)
- Time to normalization of body temperature from the start of treatment, measured in hours(5 days)
- The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment(5 days)
- The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment(5 days)
- Time to onset of complications of influenza and other ARVI from the start of treatment(14 days)
- The area under the "temperature-time" curve by the 5th day after the start of treatment(5 days)
- Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points(5 days)
- Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment(Within 6 days from the start of treatment)
- The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment(14 days)
- The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment(14 days)
- Assessment of adverse events (AEs) and serious adverse events (SAEs)(14 days)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.Influenza, HumanViral InfectionAcute Respiratory InfectionCommon ColdNCT03206346Valenta Pharm JSC161
已完成
3 期
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.Influenza, HumanViral InfectionCommon ColdAcute Respiratory InfectionNCT03191097Valenta Pharm JSC310
已完成
4 期
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in AdultsInfluenza, HumanCommon ColdAcute Respiratory InfectionNCT03154515Valenta Pharm JSC445
已完成
3 期
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral InfectionsInfluenza, HumanAcute Respiratory InfectionCommon ColdNCT05269290Valenta Pharm JSC240
招募中
4 期
Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral InfectionsInfluenza, HumanCommon ColdAcute Respiratory InfectionNCT06315400Valenta Pharm JSC80