Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

Inclusion criteria

• Patients of both sexes aged 1 month to 3 years.
• Diagnosis of acute upper respiratory infection based on a doctor's examination of the patient: body temperature at least 37.8°C when visiting a doctor + symptom scores ≥3 (presence of at least 1 general symptom and 1 nasal/ throat/chest symptom).
• The first 24 hours from the beginning of manifestations of acute upper respiratory infection.
• Acute respiratory viral infections season.
• The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms.
• Availability of a patient information sheet (Informed Consent form) signed by the patient's parents/adopters to confirm the child's participation in the clinical trial signed by one parent/adopter of patient.

Exclusion criteria

• Suspected pneumonia or bacterial infection or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset.
• Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization.
• Suspected early manifestations of diseases that have symptoms similar to ARI symptoms (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology).
• Documented (prior diagnosis) or suspected disease such as

• primary or secondary immunodeficiency: а) lymphoid immunodeficiency (T-cell and/or B-cell immunity, immunodeficiencies with predominant antibody deficit, b) phagocyte deficits; c) complement factor deficit; d) combined immunodeficiency including AIDS secondary to HIV infection; toxic, autoimmune, infectious, or radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, autoimmune and allergic diseases;
• cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, congenital malformations of the respiratory system, including malformations of upper respiratory tract, and other chronic lung disease;
• malignant neoplasm.
• Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
• Medical history of polyvalent allergy.
• Allergy/ intolerance to any of the components of medications used in the treatment.
• Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry.
• Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s).
• Mental disorders of patient's parent(s)/adopter(s).
• Patients whose parents/adopters, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
• Participation in other clinical studies in the course of 3 months (or 1-2 months for infants under two months of age) prior to the inclusion in the trial.
• Patient's parents/adopters are related to the clinical trial site's research staff directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
• The patient's parent/adopter works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family).