Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Ergoferon; Oseltamivir
Intervention description: Safety and Efficacy; Safety and Efficacy
Intervention MeSH terms: Oseltamivir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  to assess the efficacy of Ergoferon in treatment of influenza;

        -  to assess the safety of Ergoferon in treatment of influenza;

        -  to compare the efficacy of Ergoferon and Oseltamivir for treatment of influenza.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients aged 18 to 70 years.

          2. Patients who were admitted to hospital within 48 hours from the onset of influenza
             signs.

          3. Patients with body temperature ≥37,8°C when visiting a doctor + severity of influenza
             symptoms ≥4 scores (presence of at least 1 non-specific flu symptom ≥2 scores and 1
             nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the
             severity ≥1 score).

          4. Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A&B Test).

          5. The possibility to start therapy within 48 hours after the onset of the first symptoms
             of influenza.

          6. Usage of contraceptive methods by both gender patients of reproductive age during the
             trial and within 30 days after ending the participation in the trial.

          7. Availability of signed patient information sheet (Informed Consent form) for
             participation in the clinical trial.

        Exclusion Criteria:

          1. Suspected pneumonia, bacterial infection or the presence of a severe disease requiring
             usage of antibacterial drugs (including sulphanilamides) starting from Day 1 of the
             disease.

          2. Severe influenza with indications for hospitalization.

          3. Suspected early manifestations of diseases that have symptoms similar to influenza
             symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at
             the onset of systemic connective tissue disorders, hematologic neoplasms and other
             pathology).

          4. Patients requiring concurrent antiviral products forbidden by the study.

          5. Medical history of primary and secondary immunodeficiencies. а) lymphoid
             immunodeficiencies (Т-cell and/or В-cell, immunodeficiencies with predominant antibody
             deficit); b) phagocytic deficits; c) complement factor deficit; d) combined
             immunodeficiencies including AIDS secondary to HIV infection; toxic, autoimmune,
             infectious, radiation panleukopenic syndrome; total lymphocytopenic syndrome;
             polyclonal lymphocyte activation syndrome; postsplenectomic syndrome; congenital
             asplenia; abnormal immune complex syndrome associated with infectious, autoimmune and
             allergic diseases.

          6. Medical history of sarcoidosis

          7. An oncological disease/suspected oncological disease.

          8. Exacerbated or decompensated chronic diseases affecting a patient's ability to
             participate in the clinical trial.

          9. Medical history of polyvalent allergy.

         10. Allergy/intolerance to any of the components of the product used for influenza
             therapy.

         11. Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.

         12. Malabsorption syndrome, including congenital or acquired lactose deficiency or another
             disaccharide deficiency.

         13. Pregnancy, breast-feeding.

         14. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.

         15. Use of any medicine listed in the section "Prohibited concomitant treatment" within 30
             days preceding the inclusion in this study.

         16. Patients who, from the investigator's point of view, will fail to comply with the
             observation requirements of the trial or with the regimen of the study drugs.

         17. Participation in other clinical studies within 1 month prior to enrollment in the
             current trial.

         18. Patients related to the research staff of the clinical trial site who are 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.

         19. Patients employed with 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).