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

Influenza, Human Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315400
• Other study ID #: ING-07-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: December 19, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Valenta Pharm JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Common Cold
• Communicable Diseases
• Infections
• Influenza, Human
• Respiratory Tract Infections
• Virus Diseases

Intervention

Drug:
• Ingavirin®
60 mg/day for 5 days
• Placebo
1 capsule/day for 5 days

Locations

Country	Name	City	State
Russian Federation	GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation	Rostov-na-Donu
Russian Federation	GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation	Tomsk
Russian Federation	GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Valenta Pharm JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with normalization of body temperature at Visit 3 (Day 3)	Percentage of patients with body temperature <37º? with no rise above these values in the subsequent period until Visit 7	Day 0 - Day 21±1
Secondary	Timeframe for normalization of body temperature from the start of treatment, measured in hours	Time (hours) to reach body temperature <37º? with no rise above these values in the subsequent period until Visit 7 (Day 21±1)	Day 0 - Day 21±1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of vital signs: blood pressure	Blood pressure, mmHg	Day 1, Day 3, Day 6
Secondary	Assessment of vital signs: heart rate	Heart rate, bpm	Day 1, Day 3, Day 6
Secondary	Assessment of vital signs: respiratory rate	Respiratory rate, bpm	Day 1, Day 3, Day 6
Secondary	Assessment of vital signs: body temperature	Temperature, º?	Day 1 - Day 6
Secondary	Evaluation of concomitant therapy	Number and types of concomitant therapy	Day 0 - Day 21±1
Secondary	Laboratory evaluation: leukocyte formula	Precentage of white blood cells of different types	Day 1, Day 6
Secondary	Laboratory evaluation: hemoglobin	Hemoglobin, g/L	Day 1, Day 6
Secondary	Laboratory evaluation: leukocyte count	Cell/mL	Day 1, Day 6
Secondary	Laboratory evaluation: platelet count	Cell/mL	Day 1, Day 6
Secondary	Laboratory evaluation: red blood cell count	Cell/mL	Day 1, Day 6
Secondary	Laboratory evaluation: hematocrit	Hematocrit, %	Day 1, Day 6
Secondary	Laboratory evaluation: erythrocyte sedimentation rate	mm/h	Day 1, Day 6
Secondary	Laboratory evaluation: blood glucose	mmol/L	Day 1, Day 6
Secondary	Laboratory evaluation: total protein	g/L	Day 1, Day 6
Secondary	Laboratory evaluation: total bilirubin	mcmol/L	Day 1, Day 6
Secondary	Laboratory evaluation: AST	U/L	Day 1, Day 6
Secondary	Laboratory evaluation: ALT	U/L	Day 1, Day 6
Secondary	Laboratory evaluation: creatinine	mcmol/L	Day 1, Day 6
Secondary	Laboratory evaluation: urea	mmol/L	Day 1, Day 6
Secondary	Laboratory evaluation: triglycerides	mmol/L	Day 1, Day 6
Secondary	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
Secondary	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
Secondary	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