Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862883
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2023-05-15
Brief Title:
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
Organization:
Research Institute of Virology Ministry of Health of the Republic of Uzbekistan
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical research includes Determination of efficacy and acceptability of the local medicine Rutan tablets 0025 in children and teenagers 6-18 years old with COVID-19 andor 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 evolveimprove 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 participationwithdrawal 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 patients condition andor 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
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 participationwithdrawal 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 patients condition andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None