Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
Condition: Acute Upper Respiratory Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Intervention: Anaferon for children (liquid dosage form); Placebo (liquid dosage form)
Intervention description: 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.; 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 1 Month
Maximum age: 3 Years
Healthy volunteers: No

Summary:

      Purpose of the study:

        -  To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute
           upper respiratory tract infections.

        -  To assess safety of Anaferon for children liquid dosage form in the treatment of acute
           upper respiratory tract infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged 1 month to 3 years.

          2. 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).

          3. The first 24 hours from the beginning of manifestations of acute upper respiratory
             infection.

          4. Acute respiratory viral infections season.

          5. The possibility to start treatment within 24 hours of the onset of acute upper
             respiratory infection symptoms.

          6. 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:

          1. Suspected pneumonia or bacterial infection or the presence of a disease requiring
             usage of antibacterial drugs starting from day 1 of the illness onset.

          2. Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring
             hospitalization.

          3. 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).

          4. 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.

          5. Exacerbation or decompensation of chronic diseases affecting ability to participate in
             the clinical study.

          6. Medical history of polyvalent allergy.

          7. Allergy/ intolerance to any of the components of medications used in the treatment.

          8. Use of medications listed in 'Prohibited concomitant treatments/medications' within 2
             weeks before study entry.

          9. Drug use or alcohol use (more than 2 alc. units daily) by the patient's
             parent(s)/adopter(s).

         10. Mental disorders of patient's parent(s)/adopter(s).

         11. 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.

         12. 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.

         13. 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.

         14. 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).