NCT03206346已完成3 期
Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Patients 13-18 y.o.
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
- 161
- 试验地点
- 5
- 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 ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 13-17 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
- 13 Years 至 17 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 13-17
- •Patients with moderate course of influenza or other acute respiratory viral infections (AVRI)
- •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
- •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 7 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
Broad spectrum antiviral drug
干预措施: Ingavirin (Drug)
Placebo oral capsule
Placebo Comparator
Placebo capsule identical in appearance to Ingavirin capsule
干预措施: Placebo oral capsule (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)
次要结局
- Time to resolution of intoxication symptoms(7 ± 1 days)
- Time to resolution of catarrhal symptoms(7 ± 1 days)
- Time to resolution/alleviation of cough(7 ± 1 days)
研究者
研究点 (5)
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 Children 7-12 y.o.Influenza, HumanViral InfectionCommon ColdAcute Respiratory InfectionNCT03191097Valenta Pharm JSC310
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
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
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®, 90 mg Capsules in Patients With COVID-19COVID-19NCT05216497Valenta Pharm JSC233