NCT06315400招募中4 期
Double-blind, Multicenter, Randomized, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of Ingavirin®, 60 mg Capsules in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Children Aged 13-17 Years.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
研究概览
简要总结
The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 13 to 17 years inclusive.
- •Clinically established diagnosis of influenza or acute respiratory viral infection based on the presence of body temperature > 37.5 °C and at least 1 of the following symptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome: symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeball pain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis, cough).
- •Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
- •Uncomplicated course of influenza or ARVI.
- •Interval between the onset of the first symptoms of the disease and inclusion in the study no more than 36 h.
- •Availability of an informed consent form signed by one of the parents (or legal representatives) of the child for participation in the study.
- •For patients 14 years and older, a signed informed consent form for participation in the study.
排除标准
- •Hypersensitivity to any of the components included in the Ingavirin®.
- •Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
- •Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
- •Severe influenza with signs of cardiovascular failure and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
- •Signs of viral pneumonia (presence of two or more of the following symptoms: dyspnea, chest pain when coughing, systemic cyanosis, dulling of the percussion sound with symmetric evaluation of the upper and lower lungs).
- •Infectious diseases suffered during the last week before inclusion of the patient in the study.
- •"Frequently ill children" (frequency of acute respiratory illnesses during the last year 6 times or more).
- •A history of bronchial asthma.
- •A history of increased seizure activity.
- •Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, as well as make it impossible to conduct a clinical trial in the patient).
- •History of oncologic diseases, HIV infection, tuberculosis.
- •Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditary disorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
- •Participation in a clinical drug trial less than 3 months prior to the start of the study.
- •Immunization of the patient 14 days prior to the Screening Visit.
- •The need for concomitant therapy with any of the drugs listed under "Prohibited Concomitant Treatment".
- •Any other concomitant somatic diseases or conditions that, in the opinion of the investigator, make it difficult to interpret the results of treatment or result in the inability to perform the procedures in this clinical trial or pose a risk to the patient in participating in the study.
- •For female patients, a positive urine pregnancy test if menstrual cycle is present.
研究组 & 干预措施
Ingavirin®, capsules, 60 mg
Experimental
Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy.
干预措施: Ingavirin® (Drug)
Placebo
Placebo Comparator
Placebo will be administered once a day for 5 days on top of standard therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
时间窗: Day 0 - Day 21±1
Percentage of patients with body temperature \<37ºС with no rise above these values in the subsequent period until Visit 7
次要结局
- Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration(Day 0 - Day 21±1)
- Assessment of vital signs: body temperature(Day 1 - Day 6)
- Laboratory evaluation: leukocyte formula(Day 1, Day 6)
- Laboratory evaluation: hemoglobin(Day 1, Day 6)
- Laboratory evaluation: platelet count(Day 1, Day 6)
- Laboratory evaluation: red blood cell count(Day 1, Day 6)
- Laboratory evaluation: erythrocyte sedimentation rate(Day 1, Day 6)
- Laboratory evaluation: blood glucose(Day 1, Day 6)
- Laboratory evaluation: total protein(Day 1, Day 6)
- Percentage of patients with absence of intoxication syndrome(Day 0 - Day 21±1)
- Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration(Day 0 - Day 21±1)
- Assessment of vital signs: heart rate(Day 1, Day 3, Day 6)
- Laboratory evaluation: leukocyte count(Day 1, Day 6)
- Laboratory evaluation: AST(Day 1, Day 6)
- Laboratory evaluation: ALT(Day 1, Day 6)
- Laboratory evaluation: urinalysis(Day 1, Day 6)
- Percentage of patients who discontinued study due to AE/SAE(Day 0 - Day 21±1)
- Timeframe for normalization of body temperature from the start of treatment, measured in hours(Day 0 - Day 21±1)
- Percentage of patients with absence of catarrhal syndrome(Day 0 - Day 21±1)
- Frequency of adverse events (AEs) and serious adverse events (SAEs)(Day 0 - Day 21±1)
- Time of cough disappearance from the moment of treatment initiation(Day 0 - Day 21±1)
- Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy(Day 1 - Day 5)
- Assessment of vital signs: blood pressure(Day 1, Day 3, Day 6)
- Evaluation of concomitant therapy(Day 0 - Day 21±1)
- Laboratory evaluation: hematocrit(Day 1, Day 6)
- Laboratory evaluation: creatinine(Day 1, Day 6)
- Laboratory evaluation: urea(Day 1, Day 6)
- Laboratory evaluation: triglycerides(Day 1, Day 6)
- Assessment of vital signs: respiratory rate(Day 1, Day 3, Day 6)
- Laboratory evaluation: total bilirubin(Day 1, Day 6)
研究者
研究点 (3)
Loading locations...
相似试验
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
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
3 期
Efficacy and Safety of Ingavirin®, 90 mg Capsules in Patients With COVID-19COVID-19NCT05216497Valenta Pharm JSC233
已完成
3 期
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.InfluenzaCommon ColdNCT02644018Valenta Pharm JSC190