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

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: Recruiting
• Conditions: Influenza, Human; Common Cold; Acute Respiratory Infection
• Intervention / Treatment: Drug: Ingavirin®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Rostov-na-Donu, Russian Federation
    • Recruiting
    • GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
    • Contact: Tatiana V Zolotova, Prof.; Phone Number: +7-928-1049101; Email: tvzolotova1953@yandex.ru
  • Tomsk, Russian Federation
    • Recruiting
    • GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
    • Contact: Yulia G Samoilova, MD, PhD; Phone Number: +7-3822530127; Email: samoilova_y@inbox.ru
  • Yaroslavl, Russian Federation, 150000
    • Recruiting
    • GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
    • Contact: Ivan G Sitnikov, Prof.; Phone Number: +7-4852-736769; Email: sitnikov@ysmu.ru

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of patients with normalization of body temperature at Visit 3 (Day 3)	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

Outcome Measure	Measure Description	Time Frame
Timeframe for normalization of body temperature from the start of treatment, measured in hours	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	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	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	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	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	Percentage of patients with at least one severe complication of disease	Day 0 - Day 21±1
Assessment of vital signs: blood pressure	Blood pressure, mmHg	Day 1, Day 3, Day 6
Assessment of vital signs: heart rate	Heart rate, bpm	Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate	Respiratory rate, bpm	Day 1, Day 3, Day 6
Assessment of vital signs: body temperature	Temperature, ºС	Day 1 - Day 6
Evaluation of concomitant therapy	Number and types of concomitant therapy	Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula	Precentage of white blood cells of different types	Day 1, Day 6
Laboratory evaluation: hemoglobin	Hemoglobin, g/L	Day 1, Day 6
Laboratory evaluation: leukocyte count	Cell/mL	Day 1, Day 6
Laboratory evaluation: platelet count	Cell/mL	Day 1, Day 6
Laboratory evaluation: red blood cell count	Cell/mL	Day 1, Day 6
Laboratory evaluation: hematocrit	Hematocrit, %	Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate	mm/h	Day 1, Day 6
Laboratory evaluation: blood glucose	mmol/L	Day 1, Day 6
Laboratory evaluation: total protein	g/L	Day 1, Day 6
Laboratory evaluation: total bilirubin	mcmol/L	Day 1, Day 6
Laboratory evaluation: AST	U/L	Day 1, Day 6
Laboratory evaluation: ALT	U/L	Day 1, Day 6
Laboratory evaluation: creatinine	mcmol/L	Day 1, Day 6
Laboratory evaluation: urea	mmol/L	Day 1, Day 6
Laboratory evaluation: triglycerides	mmol/L	Day 1, Day 6
Laboratory evaluation: urinalysis	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)	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	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	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

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Anti-Infective Agents; Antiviral Agents; Pentanedioic acid imidazolyl ethanamide
• Other Study ID 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