NCT05862883

Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, ARVI

Studying the Efficiency of the Natural Preparation Rutan in Children in the Treatment of COVID-19, Acute Respiratory Viral Infections, and Developing Treatment Protocols

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan · Other Government
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
DRUG	Rutan 25 mg	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.
OTHER	Control group	Taking basic therapy without Rutan

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2023-05-17
• Last updated: 2023-05-17

Locations

1 site across 1 country: Uzbekistan