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

Sponsor

Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan (Other)

Overall Status

Completed

CT.gov ID

NCT05862883

Collaborator

(none)

301

Enrollment

Location

Arms

Actual Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection	Drug: Rutan 25 mg Other: Control group	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

301 participants

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.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

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Target group 201 children 6-18 years old with mild to moderate COVID-19, who were taking Rutan.	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 Names: Rutan
Other: control group 100 children 6-18 years old with mild to moderate COVID-19, who were not taking Rutan.	Other: Control group Taking basic therapy without Rutan

Arm

Intervention/Treatment

Experimental: Target group

201 children 6-18 years old with mild to moderate COVID-19, who were taking Rutan.

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 Names:

Rutan

Other: control group

100 children 6-18 years old with mild to moderate COVID-19, who were not taking Rutan.

Other: Control group

Taking basic therapy without Rutan

Outcome Measures

Primary Outcome Measures

Effectivness of therapy [twice a day for 10 days]
To evaluate the effectiveness of therapy, a PCR study will be carried out. To determine the severity of the inflammatory syndrome, CRP (C-reactive protein), procalcitonin, ferritin, IL-6, general laboratory tests and general clinical indicators will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Submission of a signed and dated informed consent form (guardian). Declared willingness to comply with all study procedures and accessibility during the study.

Children from 6 to 18 years old. Patients with PCR-confirmed COVID-19 with mild/moderate disease. U07.1. Ability to take oral medications and willingness to adhere to the regimen.

Exclusion Criteria:

Severe form of COVID-19. U07.1. Treatment with another investigational drug. Individual intolerance to the drug. The occurrence of any allergic reactions. Weighting of the general well-being of the patient and the transition to a severe form of the disease.