NCT05862883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 15, 2023

Last Update Submit

May 16, 2023

Conditions

COVID-19 Respiratory Infection

Keywords

COVID-19Rutanclinical courselaboratory valueseffectiveness

Outcome Measures

Primary Outcomes (1)

  • Effectivness of therapy

    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

Study Arms (2)

Target group

EXPERIMENTAL

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

Drug: Rutan 25 mg

control group

OTHER

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

Other: Control group

Interventions

Rutan 25 mgDRUG

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.

Also known as: Rutan
Target group
Control groupOTHER

Taking basic therapy without Rutan

control group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tashkent Institute of Virology

Tashkent, 100194, Uzbekistan

Location

Related Publications (4)

  • Keni R, Alexander A, Nayak PG, Mudgal J, Nandakumar K. COVID-19: Emergence, Spread, Possible Treatments, and Global Burden. Front Public Health. 2020 May 28;8:216. doi: 10.3389/fpubh.2020.00216. eCollection 2020.

    PMID: 32574299BACKGROUND

  • Tang T, Bidon M, Jaimes JA, Whittaker GR, Daniel S. Coronavirus membrane fusion mechanism offers a potential target for antiviral development. Antiviral Res. 2020 Jun;178:104792. doi: 10.1016/j.antiviral.2020.104792. Epub 2020 Apr 6.

    PMID: 32272173BACKGROUND

  • Gordon DE, Jang GM, Bouhaddou M, Xu J, Obernier K, White KM, O'Meara MJ, Rezelj VV, Guo JZ, Swaney DL, Tummino TA, Huttenhain R, Kaake RM, Richards AL, Tutuncuoglu B, Foussard H, Batra J, Haas K, Modak M, Kim M, Haas P, Polacco BJ, Braberg H, Fabius JM, Eckhardt M, Soucheray M, Bennett MJ, Cakir M, McGregor MJ, Li Q, Meyer B, Roesch F, Vallet T, Mac Kain A, Miorin L, Moreno E, Naing ZZC, Zhou Y, Peng S, Shi Y, Zhang Z, Shen W, Kirby IT, Melnyk JE, Chorba JS, Lou K, Dai SA, Barrio-Hernandez I, Memon D, Hernandez-Armenta C, Lyu J, Mathy CJP, Perica T, Pilla KB, Ganesan SJ, Saltzberg DJ, Rakesh R, Liu X, Rosenthal SB, Calviello L, Venkataramanan S, Liboy-Lugo J, Lin Y, Huang XP, Liu Y, Wankowicz SA, Bohn M, Safari M, Ugur FS, Koh C, Savar NS, Tran QD, Shengjuler D, Fletcher SJ, O'Neal MC, Cai Y, Chang JCJ, Broadhurst DJ, Klippsten S, Sharp PP, Wenzell NA, Kuzuoglu-Ozturk D, Wang HY, Trenker R, Young JM, Cavero DA, Hiatt J, Roth TL, Rathore U, Subramanian A, Noack J, Hubert M, Stroud RM, Frankel AD, Rosenberg OS, Verba KA, Agard DA, Ott M, Emerman M, Jura N, von Zastrow M, Verdin E, Ashworth A, Schwartz O, d'Enfert C, Mukherjee S, Jacobson M, Malik HS, Fujimori DG, Ideker T, Craik CS, Floor SN, Fraser JS, Gross JD, Sali A, Roth BL, Ruggero D, Taunton J, Kortemme T, Beltrao P, Vignuzzi M, Garcia-Sastre A, Shokat KM, Shoichet BK, Krogan NJ. A SARS-CoV-2 protein interaction map reveals targets for drug repurposing. Nature. 2020 Jul;583(7816):459-468. doi: 10.1038/s41586-020-2286-9. Epub 2020 Apr 30.

    PMID: 32353859BACKGROUND

  • Salikhov SI, Abdurakhmonov IY, Oshchepkova YI, Ziyavitdinov JF, Berdiev NS, Aisa HA, Shen J, Xu Y, Xu HE, Jiang X, Zhang L, Vypova NL, Allaberganov DS, Tagayalieva NA, Musabaev EI, Ibadova GA, Rajabov IB, Lokteva LM. Repurposing of Rutan showed effective treatment for COVID-19 disease. Front Med (Lausanne). 2023 Nov 29;10:1310129. doi: 10.3389/fmed.2023.1310129. eCollection 2023.

    PMID: 38093975DERIVED

MeSH Terms

Conditions

COVID-19Disease Progression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Erkin Musabaev, professor

    +998901869164

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 17, 2023

Study Start

June 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

UZ(1)