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
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical
      manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever

      ≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.

      Тhe physician will collect medical history information, perform an objective examination,
      record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic
      influenza test. If the swab is positive, the doctor shall obtain swab specimens from the
      nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse
      transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A
      and/or B virus. If the swab is negative for influenza the doctor shall collect a
      nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.

      If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the
      patient will be enrolled in the trial and randomized into one of the two groups: group 1
      patients will take Anaferon for children following a 5-day regimen; group 2 patients will
      receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient
      will receive a diary where they should record the child's axillary temperature data in the
      morning and evening, and score the severity of symptoms.

      The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5
      days, follow-up - 1 day; late-scheduled phone "visit" - day 14).

      At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal
      swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the
      viral load and its reduction in the course of treatment; monitor the prescribed and
      concomitant therapy, and check the patient's diary data. The phone "visit" will be made to
      elicit information from the parents regarding the patient's general health, presence/absence
      of secondary bacterial/viral complications, and use of antibacterial drugs.

      Interim statistical analysis is stipulated by the study protocol. Interim analysis will be
      performed using the data obtained from the examination and treatment of the protocol-defined
      number of patients who completed the study. Based on the expected effect, the minimum
      required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each
      group - Anaferon for children and Placebo).
    

Intervention name(s): Anaferon for Children
Intervention type(s): Drug
Intervention description(s): Anaferon for children: For oral use.
Other intervention name(s): Anaferon for Children in tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment