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.
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.
• 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.