Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections
Condition: Acute Respiratory Viral Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Intervention: Anaferon; Placebo
Intervention description: Oral administration.; Oral administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Purpose of the study:

      • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute
      respiratory viral infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either gender aged 18-70 years.

          2. Diagnosis of acute respiratory viral infection (ARVI) based on medical examination:
             axillary temperature ≥ 37,8 ° C at examination + non-specific/flu-like symptom score
             ≥4, nasal/throat/chest symptom score ≥2.

          3. The first 24 hours after ARVI onset.

          4. Seasonal rise in ARVI incidence.

          5. Patients giving their consent to use reliable contraception during the study.

          6. Signed patient information sheet (informed consent form).

        Exclusion Criteria:

          1. Suspected pneumonia, bacterial infection (including otitis media, sinuitis, urinary
             tract infection, meningitis, sepsis, etc.), requiring the administration of
             antibacterial drugs from the first day of the disease.

          2. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset
             (other infectious diseases, flu-like syndrome at the onset of systemic diseases of
             connective tissue, oncohaematological and other diseases).

          3. Clinical symptoms of severe influenza/ARVI requiring hospitalization.

          4. Subjects requiring concurrent antiviral products forbidden by the study.

          5. Medical history of primary and secondary immunodeficiency.

          6. Oncologic conditions /suspected oncologic conditions.

          7. Aggravation or decompensation of chronic diseases affecting a patient's ability to
             participate in the clinical trial.

          8. Impaired glucose tolerance, diabetes mellitus.

          9. Malabsorption syndrome, including congenital or acquired lactase or other
             disaccharidase deficiency, galactosemia.

         10. Allergy/ hypersensitivity to any component of the study drug.

         11. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the
             trial, unwillingness to use contraceptive methods during the trial.

         12. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.

         13. Course administration of the drug products specified in the section "Prohibited
             Concomitant Therapy" within two weeks prior to inclusion in the study.

         14. Patients who will not fulfill the requirements during the study or follow the order of
             administration of the studied drug products, from the Investigator's point of view.

         15. Participation in other clinical trials for 3 months prior to enrollment in this study.

         16. Patients who are related to any of the on-site research personnel directly involved in
             the study or are an immediate relative of the investigator. 'Immediate relative' means
             husband, wife, parent, son, daughter, brother, or sister (regardless of whether they
             are natural or adopted).

         17. Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees,
             temporary contract workers, designated officials responsible for carrying out the
             research or any immediate relatives of the aforementioned).