Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

Study Overview
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Brief Summary
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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 7-12 years old patients.

Official Title
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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 Children 7-12 y.o.

Conditions
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Influenza, Human, Acute Respiratory Infection, Viral Infection, Common Cold

Intervention / Treatment
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* Drug: Ingavirin
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study Male and female patients aged 7-12 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ingavirin<br> | Drug: Ingavirin<br>* Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.<br>* Other names: Imidazolyl ethanamide pentandioic acid;|
| Placebo Comparator: Placebo oral capsule<br> | Drug: Placebo oral capsule<br>* Placebo, capsules daily for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of fever | Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС) | 7 ± 1 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of intoxication symptoms | Time from the start of study treatment to resolution of all intoxication symptoms. | 7 ± 1 days | 
| Time to resolution of catarrhal symptoms | Time from the start of study treatment to resolution of all catarrhal symptoms. | 7 ± 1 days |