Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old
Condition: Acute Respiratory Viral Infection
MeSH terms: Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The multicenter double-blind placebo-controlled randomized in parallel-group. The objective
      of this study is to evaluate efficacy and safety of Raphamin in the treatment of acute
      respiratory viral infection (ARVI) in children aged 12-18 years old.
    

Detailed description: 
      Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized clinical
      trial.

      The study will enroll outpatient subjects of either gender aged 12-18 old years with clinical
      manifestations of acute respiratory viral infection (ARVI) within the first days after the
      onset of the disease. The patients will be recruited during seasonal ARVI morbidity.
      Collection of history, thermometry, objective examination, laboratory tests, recording
      concomitant therapy will be made after parent/adoptive parent signing information sheet and
      informed consent form for the child participation in the clinical study, for children ≥14
      years old after signing patient information sheet and informed consent form for children ≥14
      years old to participate in the clinical study. The severity of ARVI symptoms will be
      evaluated with a 4-point scale.

      The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be
      performed prior to therapy to confirm the viral etiology of ARVI. To rule out the infection
      caused by the new coronavirus COVID-19 (Coronavirus disease 2019), a rapid test for
      SARS-CoV-2 antigen will be made. In case of a positive SARS-CoV-2 test, the physician will
      act in accordance with the current version of the RF MoH Temporary methodological
      recommendations "Prevention, diagnosis, and therapy of new coronavirus infection (COVID-19)".

      If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit
      1 (Day 1), he/she will be randomized into one of two groups: patients of group 1 will take
      Raphamin according to the dosage regimen for 5 days; patients of group 2 will take Placebo
      using Raphamin 5-day regimen.

      The study will use an electronic patient diary (EPD) for recording morning and evening
      axillary body temperature (using a classic mercury-free thermometer) and disease symptoms
      (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any deterioration
      in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be
      recorded in a patient diary. The investigator will provide instructions on filling the diary.
      At Visit 1 the parent/adoptive parent together with an investigator will record ARVI symptom
      severity and body temperature in the diary.

      Patients will be observed for 14 days (screening, randomization - up to 1 day, treatment
      period - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14).

      During the treatment and follow-up period the patients/physicians will make 3 visits and the
      fourth "phone visit" will be scheduled additionally: 1) visits by physician/patient - on Days
      1, 5, and 7 (Visits 1, 2, and 3) - in a study center or at home; 2) "phone visit" (Visit 4) -
      on Day 14.

      At Visits 2 and 3, the investigator will perform an objective examination, document changes
      in the symptoms and concomitant medications, and check patient diaries. At Visit 3 laboratory
      tests will be performed and compliance will be checked.

      "Phone visit" will be performed to interview parents/adoptive parents about the patient's
      condition, presence/absence of secondary bacterial/viral complications, and use of
      antibiotics.

      During the study, symptomatic therapy and therapy for their co-morbidities are allowed with
      the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".
    

Intervention name(s): Raphamin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved.
On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.; Oral administration - not with food. Placebo using Raphamin scheme.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment