Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
Condition: Acute Respiratory Viral Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Intervention: Ergoferon; Placebo
Intervention description: For oral use.; 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: 287.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The international multicenter double-blind placebo-controlled randomized clinical study in
      parallel groups.The objective of this study is to obtain additional data on the efficacy and
      safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children
      aged from 6 months to 6 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both genders aged from 6 months to 6 years old.

          2. ARVI based on medical examination: oral temperature of at least 38.0°C at examination
             + total symptom severity ≥5.

          3. The first 24 hours after ARVI onset.

          4. Seasonal raise in ARVI incidence.

          5. Availability of signed information sheet for parents/adopters(Informed Consent Form)
             for participation in the clinical trial.

        Exclusion Criteria:

          1. Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media,
             urinary tract infection, etc.) requiring a prescription of antibacterial product 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 infection/ARVI requiring hospitalization.

          4. Medical history of primary and secondary immunodeficiency; oncologic conditions.

          5. Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy,
             cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations
             of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck
             and salivary and thyroid glands, etc.) which affect the patient's ability to
             participate in the clinical study.

          6. Malabsorption syndrome, including congenital or acquired lactase or other
             disaccharidase deficiency, galactosemia.

          7. Allergy/hypersensitivity to any components of the drug product used in the therapy.

          8. Course administration of the drug products specified in the section "Prohibited
             Concomitant Therapy" within two weeks prior to inclusion in the study.

          9. Patients whose parents/adoptive parents will not fulfil the requirements during the
             study or follow the order of administration of the studied drug products from the
             investigator's point of view.

         10. Participation in other clinical trials within 3 months prior to the enrollment in this
             study.

         11. The patient's parent/adoptive parent is a study specialist at the centre and is
             directly involved in the study or is an immediate family member of the investigator.
             Spouses parents, children or siblings, regardless of whether they are siblings or
             adopted are considered immediate family members.

         12. The patient's parent/adoptive parent works at OOO "NPF "MATERIA MEDICA HOLDING", i.e.
             they are employees of the Company, temporary employees on a contract basis or
             appointed official responsible for conduction of the study or their immediate family
             members.