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

May 16, 2023 updated by: Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uzbekistan
      • Tashkent, Uzbekistan, 100194
        • Tashkent Institute of Virology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectivness of therapy
Time Frame: 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.
twice a day for 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan

Investigators

  • Study Director: Erkin Musabaev, professor, +998901869164

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • А - СС - 2021 - 305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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