Clinical trial NCT06315400: Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Influenza, Human
Acute Respiratory Infection
Common Cold
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with normalization of body temperature at Visit 3 (Day 3)
timeFrame: Day 0 - Day 21±1
Secondary outcomes:
measure: Timeframe for normalization of body temperature from the start of treatment, measured in hours
timeFrame: Day 0 - Day 21±1
measure: Time of cough disappearance from the moment of treatment initiation
timeFrame: Day 0 - Day 21±1
measure: Percentage of patients with absence of catarrhal syndrome
timeFrame: Day 0 - Day 21±1
measure: Percentage of patients with absence of intoxication syndrome
timeFrame: Day 0 - Day 21±1
measure: Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy
timeFrame: Day 1 - Day 5
measure: 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
timeFrame: Day 0 - Day 21±1
measure: 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
timeFrame: Day 0 - Day 21±1
measure: Assessment of vital signs: blood pressure
timeFrame: Day 1, Day 3, Day 6
measure: Assessment of vital signs: heart rate
timeFrame: Day 1, Day 3, Day 6
measure: Assessment of vital signs: respiratory rate
timeFrame: Day 1, Day 3, Day 6
measure: Assessment of vital signs: body temperature
timeFrame: Day 1 - Day 6
measure: Evaluation of concomitant therapy
timeFrame: Day 0 - Day 21±1
measure: Laboratory evaluation: leukocyte formula
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: hemoglobin
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: leukocyte count
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: platelet count
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: red blood cell count
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: hematocrit
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: erythrocyte sedimentation rate
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: blood glucose
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: total protein
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: total bilirubin
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: AST
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: ALT
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: creatinine
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: urea
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: triglycerides
timeFrame: Day 1, Day 6
measure: Laboratory evaluation: urinalysis
timeFrame: Day 1, Day 6
measure: Frequency of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Day 0 - Day 21±1
measure: Percentage of patients who discontinued study due to AE/SAE
timeFrame: Day 0 - Day 21±1
Other outcomes:
Locations:
city: Rostov-na-Donu
country: Russian Federation
facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
city: Tomsk
country: Russian Federation
facility: GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
city: Yaroslavl
country: Russian Federation
facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Study officials:
References: