Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections

Inclusion Criteria:

1. Male and female patients aged 13 to 17 years inclusive.
2. Clinically established diagnosis of influenza or acute respiratory viral infectionbased on the presence of body temperature > 37.5 °C and at least 1 of the followingsymptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome:symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeballpain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis,cough).
3. Laboratory-confirmed diagnosis of influenza or acute respiratory viral infectionsusing one or more of the following viral antigen detection methods.
4. Uncomplicated course of influenza or ARVI.
5. Interval between the onset of the first symptoms of the disease and inclusion in thestudy no more than 36 h.
6. Availability of an informed consent form signed by one of the parents (or legalrepresentatives) of the child for participation in the study.
7. For patients 14 years and older, a signed informed consent form for participation inthe study.

Exclusion Criteria:

1. Hypersensitivity to any of the components included in the Ingavirin®.
2. Complicated course of influenza and acute respiratory viral infections (clinically andlaboratory determined bacterial infection).
3. Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugswith immunomodulatory effect) or systemic antibacterial agents 7 days prior to theScreening Visit.
4. Severe influenza with signs of cardiovascular failure and other manifestations ofinfectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
5. 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 withsymmetric evaluation of the upper and lower lungs).
6. Infectious diseases suffered during the last week before inclusion of the patient inthe study.
7. "Frequently ill children" (frequency of acute respiratory illnesses during the lastyear 6 times or more).
8. A history of bronchial asthma.
9. A history of increased seizure activity.
10. Severe, decompensated or unstable somatic diseases (any diseases or conditions thatthreaten the patient's life or worsen the patient's prognosis, as well as make itimpossible to conduct a clinical trial in the patient).
11. History of oncologic diseases, HIV infection, tuberculosis.
12. Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactosemalabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditarydisorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
13. Participation in a clinical drug trial less than 3 months prior to the start of thestudy.
14. Immunization of the patient 14 days prior to the Screening Visit.
15. The need for concomitant therapy with any of the drugs listed under "ProhibitedConcomitant Treatment".
16. Any other concomitant somatic diseases or conditions that, in the opinion of theinvestigator, make it difficult to interpret the results of treatment or result in theinability to perform the procedures in this clinical trial or pose a risk to thepatient in participating in the study.
17. For female patients, a positive urine pregnancy test if menstrual cycle is present.