XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

February 21, 2018 updated by: PHARMENTERPRISES LLC

Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)

A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment.

The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up.

In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio:

Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients).

Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control.

In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio:

Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients).

During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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

  • Russian Federation
      • Izhevsk, Russian Federation, 426063
        • Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
      • Kazan, Russian Federation, 420012
        • State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
      • Krasnodar, Russian Federation, 350063
        • State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
      • Nizhny Novgorod, Russian Federation, 603022
        • Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
      • Novosibirsk, Russian Federation, 630068
        • Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",
      • Novosibirsk, Russian Federation, 630099
        • Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",
      • Podolsk, Russian Federation, 142105
        • ; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"
      • Rostov-on-Don, Russian Federation, 344000
        • Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",
      • Ryazan', Russian Federation, 390026
        • State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"
      • Saint Petersburg, Russian Federation, 194223
        • ArsVite Severo-Zapad LLC
      • Saint Petersburg, Russian Federation, 197110
        • Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation
      • Saint Petersburg, Russian Federation, 197376
        • Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation
      • Saint Petersburg, Russian Federation, 197706
        • Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"
      • Saransk, Russian Federation, 430024
        • Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"
      • Tomsk, Russian Federation, , 634050
        • State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
      • Volgograd, Russian Federation, 400131
        • State Budgetary Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Infectious Regional Clinical Hospital № 1
      • Yaroslavl, Russian Federation, 150007
        • State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
      • Yaroslavl, Russian Federation, 150000
        • State Budgetary Institution of Higher Professional Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Yaroslavl region State Healthcare Institution Infectious Regional Clinical Hospital # 1

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women aged 18 to 45 years (inclusively).
  2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.
  3. Uncomplicated course of ARVI or influenza.
  4. The onset of symptoms no more than 36h prior to the inclusion into the study.
  5. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
  6. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
  7. Signed Informant Consent Form.

Exclusion Criteria:

The patient will be deemed ineligible for the study meeting any of the following criteria:

  1. Complicated course of influenza or ARVI (including the presence / development of bacterial infection).
  2. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
  3. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
  4. Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
  5. Infectious diseases during the last week before including into the study.
  6. History of bronchial asthma.
  7. History of increased convulsive activity.
  8. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study).
  9. History of oncological diseases, HIV, tuberculosis.
  10. Hypersensitivity to excipients of the XC8.
  11. Diabetes mellitus, lactose intolerance, lactase deficiency.
  12. Drug or alcohol abuse.
  13. Participation in any other clinical trial in the last 90 days.
  14. Pregnancy or lactation.
  15. Military or prison populations.
  16. Impossibility or inability to comply with the study procedures.
  17. A member of the investigator's family or other person interested in the results of the study
  18. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
  19. History of renal insufficiency.

  20. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01.

    -

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XC8 20 mg and Placebo (Group A)
XC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period
Drug: XC8 20 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Experimental: XC8 100 mg and Placebo (Group B)

XC8 100 mg orally.

1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period
Drug: XC8 100 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Experimental: XC8 200 mg and Placebo (Group C)
XC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period.
Drug: XC8 200 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Placebo Comparator: Placebo (Group D)
Placebo orally.
Drug: XC8 20 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Drug: XC8 100 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Drug: XC8 200 mg
once daily during 5 days.
Other Names:
  • Нistamine glutarimide
Drug: Placebo
once daily during 5 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to sustained improvement in clinical symptoms
Time Frame: up to Day 5
Severity Rating Scale for ARVI (<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (<37°C) (estimated by Kaplan-Meier), established according to patient diaries.
up to Day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body temperature below 37°C without further elevation
Time Frame: up to Day 8
Time to normalization of body temperature since the symptoms onset, measured in hours
up to Day 8

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PHARMENTERPRISES LLC

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FLU-XC8-01

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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