Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections

March 28, 2024 updated by: Valenta Pharm JSC

Double-blind, Multicenter, Randomized, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of Ingavirin®, 60 mg Capsules in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Children Aged 13-17 Years.

The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.

Study Overview

Status

Status

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

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 (Estimated)

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.
80

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 4

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
      • Rostov-na-Donu, Russian Federation
        • Recruiting
        • GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
        • Contact:
      • Tomsk, Russian Federation
        • Recruiting
        • GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
        • Contact:
      • Yaroslavl, Russian Federation, 150000
        • Recruiting
        • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female patients aged 13 to 17 years inclusive.
  2. Clinically established diagnosis of influenza or acute respiratory viral infection based on the presence of body temperature > 37.5 °C and at least 1 of the following symptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome: symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeball pain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis, cough).
  3. Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
  4. Uncomplicated course of influenza or ARVI.
  5. Interval between the onset of the first symptoms of the disease and inclusion in the study no more than 36 h.
  6. Availability of an informed consent form signed by one of the parents (or legal representatives) of the child for participation in the study.
  7. For patients 14 years and older, a signed informed consent form for participation in the study.

Exclusion Criteria:

  1. Hypersensitivity to any of the components included in the Ingavirin®.
  2. Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
  3. Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
  4. Severe influenza with signs of cardiovascular failure and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
  5. Signs of viral pneumonia (presence of two or more of the following symptoms: dyspnea, chest pain when coughing, systemic cyanosis, dulling of the percussion sound with symmetric evaluation of the upper and lower lungs).
  6. Infectious diseases suffered during the last week before inclusion of the patient in the study.
  7. "Frequently ill children" (frequency of acute respiratory illnesses during the last year 6 times or more).
  8. A history of bronchial asthma.
  9. A history of increased seizure activity.
  10. Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, as well as make it impossible to conduct a clinical trial in the patient).
  11. History of oncologic diseases, HIV infection, tuberculosis.
  12. Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditary disorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
  13. Participation in a clinical drug trial less than 3 months prior to the start of the study.
  14. Immunization of the patient 14 days prior to the Screening Visit.
  15. The need for concomitant therapy with any of the drugs listed under "Prohibited Concomitant Treatment".
  16. Any other concomitant somatic diseases or conditions that, in the opinion of the investigator, make it difficult to interpret the results of treatment or result in the inability to perform the procedures in this clinical trial or pose a risk to the patient in participating in the study.
  17. For female patients, a positive urine pregnancy test if menstrual cycle is present.

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: Ingavirin®, capsules, 60 mg
Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy.
Drug: Ingavirin®
60 mg/day for 5 days
Placebo Comparator: Placebo
Placebo will be administered once a day for 5 days on top of standard therapy.
Drug: Placebo
1 capsule/day for 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
Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
Time Frame: Day 0 - Day 21±1
Percentage of patients with body temperature <37ºС with no rise above these values in the subsequent period until Visit 7
Day 0 - Day 21±1

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
Timeframe for normalization of body temperature from the start of treatment, measured in hours
Time Frame: Day 0 - Day 21±1
Time (hours) to reach body temperature <37ºС with no rise above these values in the subsequent period until Visit 7 (Day 21±1)
Day 0 - Day 21±1
Time of cough disappearance from the moment of treatment initiation
Time Frame: Day 0 - Day 21±1
Disappearance of cough; no recurrence of cough in the following days of observation
Day 0 - Day 21±1
Percentage of patients with absence of intoxication syndrome
Time Frame: Day 0 - Day 21±1
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Day 0 - Day 21±1
Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy
Time Frame: Day 1 - Day 5
Average body temperature (two measurements per a day)
Day 1 - Day 5
Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Time Frame: Day 0 - Day 21±1
Percentage of patients with at least one complication of disease
Day 0 - Day 21±1
Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Time Frame: Day 0 - Day 21±1
Percentage of patients with at least one severe complication of disease
Day 0 - Day 21±1
Assessment of vital signs: blood pressure
Time Frame: Day 1, Day 3, Day 6
Blood pressure, mmHg
Day 1, Day 3, Day 6
Assessment of vital signs: heart rate
Time Frame: Day 1, Day 3, Day 6
Heart rate, bpm
Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate
Time Frame: Day 1, Day 3, Day 6
Respiratory rate, bpm
Day 1, Day 3, Day 6
Assessment of vital signs: body temperature
Time Frame: Day 1 - Day 6
Temperature, ºС
Day 1 - Day 6
Evaluation of concomitant therapy
Time Frame: Day 0 - Day 21±1
Number and types of concomitant therapy
Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula
Time Frame: Day 1, Day 6
Precentage of white blood cells of different types
Day 1, Day 6
Laboratory evaluation: hemoglobin
Time Frame: Day 1, Day 6
Hemoglobin, g/L
Day 1, Day 6
Laboratory evaluation: leukocyte count
Time Frame: Day 1, Day 6
Cell/mL
Day 1, Day 6
Laboratory evaluation: platelet count
Time Frame: Day 1, Day 6
Cell/mL
Day 1, Day 6
Laboratory evaluation: red blood cell count
Time Frame: Day 1, Day 6
Cell/mL
Day 1, Day 6
Laboratory evaluation: hematocrit
Time Frame: Day 1, Day 6
Hematocrit, %
Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate
Time Frame: Day 1, Day 6
mm/h
Day 1, Day 6
Laboratory evaluation: blood glucose
Time Frame: Day 1, Day 6
mmol/L
Day 1, Day 6
Laboratory evaluation: total protein
Time Frame: Day 1, Day 6
g/L
Day 1, Day 6
Laboratory evaluation: total bilirubin
Time Frame: Day 1, Day 6
mcmol/L
Day 1, Day 6
Laboratory evaluation: AST
Time Frame: Day 1, Day 6
U/L
Day 1, Day 6
Laboratory evaluation: ALT
Time Frame: Day 1, Day 6
U/L
Day 1, Day 6
Laboratory evaluation: creatinine
Time Frame: Day 1, Day 6
mcmol/L
Day 1, Day 6
Laboratory evaluation: urea
Time Frame: Day 1, Day 6
mmol/L
Day 1, Day 6
Laboratory evaluation: triglycerides
Time Frame: Day 1, Day 6
mmol/L
Day 1, Day 6
Laboratory evaluation: urinalysis
Time Frame: Day 1, Day 6
Urune color, transparency, specific gravity, pH, presence of protein, glucose, bilirubin, microscopy of urine sediment (epithelium, erythrocytes, leukocytes, cylinders, bacteria, salts)
Day 1, Day 6
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Day 0 - Day 21±1
Total number and frequency of AEs and SAEs stratified by severity and frequency
Day 0 - Day 21±1
Percentage of patients who discontinued study due to AE/SAE
Time Frame: Day 0 - Day 21±1
Percentage of patients who discontinued study participation early due to the occurrence of AE/SAE and time to dropout due to AE/SAE
Day 0 - Day 21±1
Percentage of patients with absence of catarrhal syndrome
Time Frame: Day 0 - Day 21±1
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Day 0 - Day 21±1

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

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.
December 19, 2023

Primary Completion (Estimated)

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.
December 31, 2025

Study Completion (Estimated)

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.
December 31, 2025

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).
March 11, 2024

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.
March 11, 2024

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.
March 18, 2024

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.
April 1, 2024

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.
March 28, 2024

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, 2024

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.
  • ING-07-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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