Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o. (ACCORD)

June 7, 2016 updated by: Valenta Pharm JSC

Double Blind Randomized Placebo-controlled Multicenter Study to Evaluate Clinical Efficacy and Safety of Ingavirin®, Capsules 30 mg, in 3-6 Years Old Patients With Influenza and Other Acute Respiratory Viral Infections in the Course of Standard Therapy

The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.

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.

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.
190

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 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
      • Kazan, Russian Federation
        • GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation
      • Krasnoyarsk, Russian Federation
        • GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation
      • Moscow, Russian Federation
        • FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation
      • Moscow, Russian Federation
        • I.M. Sechenov First Moscow State Medical University
      • Moscow, Russian Federation
        • Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department
      • Novosibirsk, Russian Federation
        • GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation"
      • Perm, Russian Federation
        • Children's city outpatients clinic № 5
      • Rostov-na-Donu, Russian Federation
        • Children's city outpatients clinic № 4
      • Rostov-na-Donu, Russian Federation
        • GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
      • Saint-Petersburg, Russian Federation
        • FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency"
      • Saransk, Russian Federation
        • FGBOU VPO "Mordov State University n.a. N.P. Ogarev"
      • Tomsk, Russian Federation
        • GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
      • Yaroslavl, Russian Federation
        • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation

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

9 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study.
  • Male and female patients aged 3-6.
  • Patients with moderate course of influenza or other acute respiratory viral infections.

  • Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:

    • Intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs;
    • Catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion.
  • Established diagnosis J06.9, J10, J11, in accordance with ICD-10.
  • Uncomplicated course of influenza and other ARVI.
  • Interval between onset of symptoms and enrollment to the study of not more than 36 hours.

Exclusion Criteria:

  • Complicated course of influenza and other acute respiratory viral infections.
  • Treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 14 days prior to the screening visit.
  • Severe influenza or other ARVI with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes.
  • Signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs.
  • Infectious diseases within the last week prior to enrollment.
  • "RRI children" (incidence of ARVI within the last 12 months is 6 times or more).
  • Asthma history.
  • History of increased seizure activity.
  • Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis and also make it impossible to conduct a clinical study in the patient).
  • Cancer, HIV infection, tuberculosis, including those in history.
  • Hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of Ingavirin product.
  • Diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase.
  • Participation of the patient in any other clinical trial within the last 90 days prior to enrollment.

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: Quadruple

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: Ingavirin
Ingavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
Drug: Imidazolyl ethanamide pentandioic acid
Other Names:
  • Ingavirin
Placebo Comparator: Placebo
Placebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal.
Drug: placebo

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 decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature
Time Frame: 5 days
Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start.
5 days

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
Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points
Time Frame: 5 days
5 days
Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame: Within 6 days from the start of treatment
Within 6 days from the start of treatment
The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment
Time Frame: 5 days
5 days
Time to normalization of body temperature from the start of treatment, measured in hours
Time Frame: 5 days
Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start
5 days
The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame: 5 days
5 days
The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment
Time Frame: 5 days
5 days
The area under the "temperature-time" curve by the 5th day after the start of treatment
Time Frame: 5 days
5 days
The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Time Frame: 14 days
14 days
The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment
Time Frame: 14 days
14 days
Time to onset of complications of influenza and other ARVI from the start of treatment
Time Frame: 14 days
14 days
Assessment of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 14 days

Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -

  • Portion of patients who developed one or more SAE during the study
  • Portion of patients who developed one or more AE during the study
  • Portion of patients who developed one or more severe AE during the study
  • Portion of patients who developed one or more AE with definite relationship to the investigational product/ placebo during the study
  • Portion of patients who developed one or more AE with definite or probable relationship to the investigational product/ placebo during the study
14 days

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.
Valenta Pharm JSC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atlant Clinical Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC
  • Principal Investigator: Yuriy V. Lobzin, MD, PhD, Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation

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

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.
January 1, 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.
May 1, 2016

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.
May 1, 2016

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).
December 22, 2015

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.
December 29, 2015

First Posted (Estimate)

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.
December 31, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
June 9, 2016

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.
June 7, 2016

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, 2016

More Information

Terms related to this study

Keywords

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.
  • ING-03-02-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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