Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 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 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.

Official Title
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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

Conditions
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Common Cold, Influenza

Intervention / Treatment
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* Drug: Imidazolyl ethanamide pentandioic acid
* Drug: placebo


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 3-6. 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-10. 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 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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>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. | Drug: Imidazolyl ethanamide pentandioic acid<br> <br> * Other names: Ingavirin;|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start | 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 | 
| The area under the temperature-time curve by the 5th day after the start of treatment |  | 5 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 | 
| 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 | 
| Time to onset of complications of influenza and other ARVI from the start of treatment |  | 14 days | 
| Assessment of adverse events (AEs) and serious adverse events (SAEs) | Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of - Portion of patients who developed one or more SAE during the study Portion of patients who developed one or more AE during the study Portion of patients who developed one or more severe AE during the study Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ingavirin, Common Cold, Influenza, Acute Respiratory Viral Infections, pediatric clinical trial, Imidazolyl ethanamide pentandioic acid