Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
Condition: Influenza and Acute Respiratory Viral Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Virus Diseases
Intervention: Anaferon for Children
Intervention description: Anaferon for children: For oral use.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 569.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

      • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment
      of influenza and acute respiratory viral infections in children
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged 3-12 years inclusively.

          2. Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥
             38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2
             and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).

          3. The first 24 hours from the beginning of manifestations of influenza/ARVI.

          4. The possibility to start therapy within 24 hours from the first symptoms of ARVI.

          5. Availability of a patient information sheet (Informed Consent form) for
             parents/adoptive parents for participation in the study signed by one of the
             parents/adoptive parents.

        Exclusion Criteria:

          1. Suspected pneumonia, bacterial infection or severe disease requiring antibacterial
             products (including sulfanilamides) starting from the first day of the disease.

          2. Clinical symptoms of severe influenza/ARVI requiring hospitalization.

          3. Suspected initial manifestations of the diseases having the symptoms similar to the
             ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of
             systemic connective tissue diseases, oncohematological and other diseases).

          4. Medical history of primary and secondary immunodeficiencies: а) lymphoid system
             immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody
             deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined
             immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune,
             infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome;
             polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital
             asplenia; immune complex pathological syndrome associated with infectious, autoimmune
             and allergic diseases.

          5. Medical history of sarcoidosis.

          6. Oncology.

          7. Exacerbation or decompensation of chronic diseases affecting ability to participate in
             the clinical study.

          8. Medical history of polyvalent allergy.

          9. Allergy/intolerance to any of the components of medications used in the treatment.

         10. Malabsorption syndrome, including congenital or acquired lactase or other
             disaccharidase deficiency, galactosemia.

         11. Intake of medicines listed in the section "Prohibited concomitant therapy" within 1
             month prior to the inclusion in the study.

         12. Drug addiction, alcohol consumption at more than 2 alcohol units per day by the
             subject's parents/adoptive parents.

         13. Mental diseases of the subject, parents/adoptive parents.

         14. Subjects whose parents/adoptive parents, according to the investigator's point of
             view, will not follow the observation requirements during the study or study product
             dosing regimen.

         15. Participation in other clinical studies within 3 months prior to the inclusion in the
             study.

         16. Parent/adoptive parent of the subject is related to the investigator team of medical
             facility directly involved in the study or is a close relative of the investigator.
             Close relatives include spouse, parents, children or brothers (sisters) regardless of
             whether they are biological or adoptive ones.

         17. Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding",
             i.e. is the company official, temporary contract worker or an appointed official
             responsible for the study or their close relatives.