Conducting Clinical Trials of the Medicine "Rutan Tablets 0.1g" No. 10 in the Complex Therapy of COVID-19

NCT05859919 | Completed Phase 2 DMC

• 1 other identifier: C-И-45
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of the registered drug Rutan 0.1 against SARS-CoV-2 in patients with COVID-19. The main group (30 people) - patients with COVID-19 who are on inpatient treatment who were prescribed the drug Rutan 0.1, 1 tablet 2 times a day for 10 days. The control group (27 people) - patients with COVID-19 who are hospitalized and received therapy according to the National Temporary Protocol for the management of patients with COVID-19.

Conditions

Patients With COVID-19

Keywords

COVID-19; SARS-CoV-2; Rutan

Outcome Measures

Primary Outcomes (1)

• Check the safety and effectiveness of the drug "Rutan 0.1"

  In the experimental group, on days 4-5 of hospitalization in the hospital after taking rutan 100 mg, the PCR indicators for covid 19 were negative, which indicates the minimum duration of viremia in this group, and there were generally no cases of deterioration in well-being with the development of critical conditions requiring oxygenation. A statistically significant difference was found between the indicators at admission and after 4-5 days between the control and experimental groups in terms of quantitative indicators of C reactive protein.

  The duration of the course of treatment is 10 days

Study Arms (2)

The main group receiving the drug "Rutan 0.1" and

EXPERIMENTAL

The main group will receive the drug "Rutan 0.1"

Drug: The drug "Rutan 0.1".

The control group not receiving Rutan 0.1

OTHER

The control group will not be given the study drug Rutan 0.1

Other: Basic treatment

Interventions

The drug "Rutan 0.1". DRUG

Active ingredient: (3,6-bis-O-galloyl-1,2,4-tri-O-galloyl-β-D-glucose). Active substance: "Rutan 0.1" 100mg. Excipients: potato starch, calcium stearate, lactulose.

Also known as: Rutan

The main group receiving the drug "Rutan 0.1" and

Basic treatment OTHER

Basic treatment without the drug "Rutan 0.1".

The control group not receiving Rutan 0.1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Providing a signed and dated informed consent form.
• Declared willingness to comply with all study procedures and availability during the study.
• Man or woman over the age of 18.
• Patients with PCR-confirmed COVID-19 with mild/moderate disease. U07.1.
• Ability to take oral medications and willingness to adhere to the regimen.
• For women of childbearing potential: use of highly effective contraceptives for at least 1 month before screening and agree to use such a method during study participation and for an additional 4 weeks after the end.
• For men of reproductive potential: use condoms or other methods to ensure effective contraception with a partner.
• Agree to adhere to the lifestyle principles throughout the study period.

You may not qualify if:

• Pregnancy or lactation.
• Severe form of COVID-19 disease. U07.1.
• Treatment with another investigational drug.
• Individual intolerance to the drug.
• The occurrence of any allergic reactions.
• Weighting of the general state of health of the patient and the transition to a severe form of the disease.

Sponsors & Collaborators

• Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan: lead

Study Sites (1)

Erkin Musabaev

Tashkent, 100194, Uzbekistan

Location

Related Publications (2)

• Tempestilli M, Caputi P, Avataneo V, Notari S, Forini O, Scorzolini L, Marchioni L, Ascoli Bartoli T, Castilletti C, Lalle E, Capobianchi MR, Nicastri E, D'Avolio A, Ippolito G, Agrati C; COVID 19 INMI Study Group. Pharmacokinetics of remdesivir and GS-441524 in two critically ill patients who recovered from COVID-19. J Antimicrob Chemother. 2020 Oct 1;75(10):2977-2980. doi: 10.1093/jac/dkaa239.

  PMID: 32607555 BACKGROUND

• Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.

  PMID: 32083985 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erkin Musabaev, Professor

  Rersearch Institute of Virology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study will be a series of comparisons with two groups. The main group will receive the drug "Rutan 0.1". The control group will not be given the study drug.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 16, 2023
• Study Start: October 12, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)