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Patients With COVID-19Phase 2NCT05859919

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

A Phase 2 study testing The drug "Rutan 0.1". and Basic treatment in people with Patients With COVID-19, run by Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan at 1 site in Uzbekistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patients With COVID-19
What is being tested?
The drug "Rutan 0.1". and Basic treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUzbekistan
Study dates
12 Oct 2020to 30 Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Uzbekistan1 site

  • Erkin Musabaev

    Tashkent, 100194

Other trials in Uzbekistan

About this study

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

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.

Read the detailed description

This study is a randomized, open-label, controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Rutan 0.1, in hospitalized adult patients diagnosed with COVID-19. 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. 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 (30 patients) will be prescribed Rutan 0.1 tablets, along with the therapy recommended at the time of the study. The course of treatment will be - on the first day, 1 tablet 3 times a day, in the following days - 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 (27 patients) will receive the current recommended treatment at the time of the study without the use of investigational drug.

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.

Being tested
The drug "Rutan 0.1"., Basic treatment
Keywords
COVID-19, SARS-CoV-2, Rutan
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The drug "Rutan 0.1".Drug

    Also called Rutan

    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.

  • Basic treatmentOther

    Basic treatment without the drug "Rutan 0.1".

Study groups in NCT05859919
Study groupRoleWhat they receive
The main group receiving the drug "Rutan 0.1" andExperimentalThe main group will receive the drug "Rutan 0.1"
Receives: Drug: The drug "Rutan 0.1".
The control group not receiving Rutan 0.1OtherThe control group will not be given the study drug Rutan 0.1
Receives: Other: Basic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The duration of the course of treatment is 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start12 Oct 2020
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05859919
Sponsor's protocol ID
C-И-45
Status last verified
May 2023
First submitted
15 May 2023
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32607555

  • 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.

    PubMed 32083985

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The drug "Rutan 0.1". and Basic treatment in people with Patients With COVID-19, run by Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan at 1 site in Uzbekistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Check the safety and effectiveness of the drug "Rutan 0.1" (time frame: The duration of the course of treatment is 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05859919, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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