Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections
- Conditions
- Acute Respiratory InfectionCommon ColdInfluenza, Human
- Interventions
- Drug: PlaceboDrug: Ingavirin®
- Registration Number
- NCT06315400
- Lead Sponsor
- Valenta Pharm JSC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Male and female patients aged 13 to 17 years inclusive.
- 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).
- Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
- Uncomplicated course of influenza or ARVI.
- Interval between the onset of the first symptoms of the disease and inclusion in the study no more than 36 h.
- Availability of an informed consent form signed by one of the parents (or legal representatives) of the child for participation in the study.
- For patients 14 years and older, a signed informed consent form for participation in the study.
- Hypersensitivity to any of the components included in the Ingavirin®.
- Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
- Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
- 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).
- 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).
- Infectious diseases suffered during the last week before inclusion of the patient in the study.
- "Frequently ill children" (frequency of acute respiratory illnesses during the last year 6 times or more).
- A history of bronchial asthma.
- A history of increased seizure activity.
- 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).
- History of oncologic diseases, HIV infection, tuberculosis.
- Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditary disorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
- Participation in a clinical drug trial less than 3 months prior to the start of the study.
- Immunization of the patient 14 days prior to the Screening Visit.
- The need for concomitant therapy with any of the drugs listed under "Prohibited Concomitant Treatment".
- 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.
- For female patients, a positive urine pregnancy test if menstrual cycle is present.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered once a day for 5 days on top of standard therapy. Ingavirin®, capsules, 60 mg Ingavirin® Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy.
- Primary Outcome Measures
Name Time Method Percentage of patients with normalization of body temperature at Visit 3 (Day 3) 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
- Secondary Outcome Measures
Name Time Method Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy Day 1 - Day 5 Average body temperature (two measurements per a day)
Assessment of vital signs: blood pressure Day 1, Day 3, Day 6 Blood pressure, mmHg
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 Day 0 - Day 21±1 Percentage of patients with at least one severe complication of disease
Assessment of vital signs: body temperature Day 1 - Day 6 Temperature, ºС
Laboratory evaluation: leukocyte formula Day 1, Day 6 Precentage of white blood cells of different types
Laboratory evaluation: hemoglobin Day 1, Day 6 Hemoglobin, g/L
Laboratory evaluation: platelet count Day 1, Day 6 Cell/mL
Laboratory evaluation: red blood cell count Day 1, Day 6 Cell/mL
Laboratory evaluation: erythrocyte sedimentation rate Day 1, Day 6 mm/h
Laboratory evaluation: blood glucose Day 1, Day 6 mmol/L
Laboratory evaluation: total protein Day 1, Day 6 g/L
Percentage of patients with absence of intoxication syndrome 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)
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 Day 0 - Day 21±1 Percentage of patients with at least one complication of disease
Assessment of vital signs: heart rate Day 1, Day 3, Day 6 Heart rate, bpm
Laboratory evaluation: leukocyte count Day 1, Day 6 Cell/mL
Laboratory evaluation: AST Day 1, Day 6 U/L
Laboratory evaluation: ALT Day 1, Day 6 U/L
Laboratory evaluation: urinalysis 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)
Percentage of patients who discontinued study due to AE/SAE 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
Timeframe for normalization of body temperature from the start of treatment, measured in hours 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)
Percentage of patients with absence of catarrhal syndrome 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)
Frequency of adverse events (AEs) and serious adverse events (SAEs) Day 0 - Day 21±1 Total number and frequency of AEs and SAEs stratified by severity and frequency
Time of cough disappearance from the moment of treatment initiation Day 0 - Day 21±1 Disappearance of cough; no recurrence of cough in the following days of observation
Evaluation of concomitant therapy Day 0 - Day 21±1 Number and types of concomitant therapy
Laboratory evaluation: hematocrit Day 1, Day 6 Hematocrit, %
Laboratory evaluation: creatinine Day 1, Day 6 mcmol/L
Laboratory evaluation: urea Day 1, Day 6 mmol/L
Laboratory evaluation: triglycerides Day 1, Day 6 mmol/L
Assessment of vital signs: respiratory rate Day 1, Day 3, Day 6 Respiratory rate, bpm
Laboratory evaluation: total bilirubin Day 1, Day 6 mcmol/L
Trial Locations
- Locations (3)
GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
🇷🇺Tomsk, Russian Federation
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
🇷🇺Rostov-na-Donu, Russian Federation
GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
🇷🇺Yaroslavl, Russian Federation