Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, ARVI
Condition: COVID-19 Respiratory Infection
MeSH terms: Infections; COVID-19; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical research includes Determination of efficacy and acceptability of the local medicine
      "Rutan tablets 0,025" in children and teenagers 6-18 years old with COVID-19 and/or acute
      respiratory viral infections. And also the purpose of the study was to study clinical and
      laboratory changes when using Rutan in patients with Covid 19 clinical methods such as
      collection of anamnesis, dynamic examination of patients, catamnestic observation - a
      telephone survey, as well as biochemical, immunological, virologic PCR and ELISA tests.
    

Detailed description: 
      This study is a randomized, open-label, controlled trial to evaluate the safety and efficacy
      of a novel therapeutic agent, Rutan 25 mg, in hospitalized child patients diagnosed with
      COVID-19. The study will be a series of comparisons with two groups. The main group will
      receive the drug "Rutan 25 mg". The control group will not be given the study drug. There
      will be continuous monitoring to stop the study due to futility, efficacy or safety. Because
      of the likelihood that the baseline standards for maintenance therapy may evolve/improve over
      time, safety and efficacy comparisons will adapt.

      Randomization will be based on: Card system (the patient will be asked to choose one of two
      cards with the same drawings on the visible side, and after choosing, when turning over the
      cards, it will be determined which group the patient will be included) Patients of the main
      group (210 patients) will be prescribed Rutan 25 mg tablets, along with the therapy
      recommended at the time of the study. The course of treatment will be - on the first day, 1
      tablet 2 times a day. The duration of the course of treatment is 10 days, with good
      tolerability of the drug.

      The comparison group (100 patients) will receive the current recommended treatment at the
      time of the study without the use of investigational medicine.

      Screening failures are defined by participants who agreed to participate in a clinical trial
      but were not subsequently randomized to participate in the study. A minimum set of
      information about monitoring failures is required to ensure transparent reporting, compliance
      with the publication of the Consolidated Reporting Standards (CONSORT), and responses to
      regulatory requests. The minimum information includes demographics, monitoring failure
      details, eligibility criteria, and any serious adverse events (SAEs).

      Discontinuation of participation/withdrawal of a participant means termination of
      participation in the study, and the remaining study procedures must be interrupted and
      replaced by another participant, as indicated in the study protocol. Any clinically
      significant changes in the patient's condition and/or laboratory values will be reported as
      an adverse event (AE) by the investigator. The researcher has the right to make changes or
      terminate the study.
    

Intervention name(s): Rutan 25 mg; Control group
Intervention type(s): Drug; Other
Intervention description(s): Active ingredient: (3,6-bis-O-galloyl-1,2,4-tri-O-galloyl-β-D-glucose). Active substance: "Rutan 25 mg. Excipients: potato starch, calcium stearate, lactulose.; Taking basic therapy without Rutan
Other intervention name(s): Rutan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Main group consisting of 201 children of 6-18 years old with mild and moderate COVID-19 form who were treated at the specialized clinic "Zangiota 1" and were taking Rutan. Control group consisting of 100 children of 6-18 years old with mild and moderate COVID-19 form who were treated at the specialized clinic "Zangiota 1" and were not taking Rutan.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; Rutan; clinical course; laboratory values; effectiveness