Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat
Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat
This multicenter prospective double blinded placebo-controlled randomized study is designed
 to to evaluate clinical efficacy, tolerability and safety of medical product Derinat®,
 solution for external and local use 0.25% in acute infections of respiratory system in
 children
This is a multi-center, double-blind, randomized phase III-IV clinical trial in parallel
 groups to evaluate the efficacy and safety of Derinat versus Placebo in patients with acute
 upper respiratory tract infection.

 The study will include only patients with mild to moderate acute upper respiratory tract
 infection, without complications. According to the recommendations of the FDA (Guidance for
 Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis) this category of
 patients is the best suited for placebo-controlled studies, because the expected serious
 risks without treatment are negligible. For studies evaluating the therapy of patients with
 mild to moderate acute respiratory upper respiratory tract infection without complications, a
 placebo-controlled trial design is preferred, as opposed to designs with no less efficacy
 (non-inferiority).

 This study provides for the inclusion of both outpatient patients and patients admitted to
 the hospital for epidemiological indications (i.e. patients with acute respiratory infection
 of the upper respiratory tract of mild and moderate severity without complications that pose
 an epidemic risk.

 Assessment of criteria of severity of acute respiratory infection of the upper respiratory
 tract will be carried out by Investigator based on standards of diagnosis and treatment of
 infectious diseases in children at the stages of medical care, depending on the forms of
 severity of the disease.

 The study is planned sequentially in 5 age groups. The study begins with the older age group
 and as the results on the safety of the drug are obtained, in the course of the study, it is
 possible to move to younger age groups
Inclusion Criteria:

 1. Signed informed consent

 2. Male and female patients.

 3. The age of the child at the time of first intranasal administration of drug for age
 group 1: 12 years to <18 years; for age group 2: from 6 years to <12 years; for age
 group 3: from 2 years to <6 years; for age group 4: 7 months to <2 years; for age
 group 5: from 0 months to 6 months.

 4. Outpatient and inpatient patients hospitalized for epidemiological reasons, with a
 diagnosis of acute respiratory infection of the upper respiratory tract of mild to
 moderate severity. (ICD 10: J00 - J06 Acute respiratory infections of the upper
 respiratory tract).

 5. The positive result of the enzyme immunoassay express test for pathogens of acute
 respiratory infection of the upper respiratory tract on screening.

 6. At least one episode of body temperature up to 38C and above within 48 hours prior to
 screening.

 7. Presence of at least one of the following mild to moderate symptoms at screening:
 headache, weakness/malaise, muscle pain/aching, feeling of heat/chills.

 8. The duration of the disease is not more than 48 hours at the time of screening
 according to the patient/parents/adoptive parents.

 9. Adequate contraceptive methods during the study for the patients with childbearing
 potential

 Exclusion Criteria:

 1. Positive express test (in urine) for pregnancy in patients with childbearing potential
 (menarche).

 2. Individual intolerance or hypersensitivity to any of the components of the drug
 according to the medical history.

 3. Taking any drugs with immunomodulatory effect less than 30 days before screening
 according to medical history.

 4. The presence of complications of acute respiratory infection of the upper respiratory
 tract, signs of severe disease at the time of screening (fever more than 39ºC, febrile
 convulsions).

 5. Acute infectious diseases: diphtheria, measles, infectious mononucleosis, herpes type
 1 and 2, rubella, scarlet fever, acute BGSA-tonsillopharyngitis at the time of
 screening or 30 days before screening.

 6. Chronic diseases of the respiratory system (Bronchial asthma, COPD).

 7. HIV infection, chronic viral hepatitis B or C (according to history).

 8. Impaired renal function with serum creatinine level more than 1.5 times higher than
 the upper limit of the normal range.

 9. Severe liver failure or active liver disease (including viral hepatitis B or C) and
 increase of ALT and AST more than 5 times of upper limit of the normal range.

 10. Participation in any clinical trials and / or taking an experimental drug within 30
 days prior to the screening visit.

 11. Other significant diseases and conditions of the patient, including mental and
 physical diseases