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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
60 mg/day for 5 days
1 capsule/day for 5 days
GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation
Rostov-on-Don, Russia
RECRUITINGGBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation
Tomsk, Russia
RECRUITINGGBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation
Yaroslavl, Russia
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
Time frame: Day 0 - Day 21±1
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
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Percentage of patients with at least one complication of disease
Time frame: 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
Time frame: Day 0 - Day 21±1
Assessment of vital signs: blood pressure
Blood pressure, mmHg
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: heart rate
Heart rate, bpm
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate
Respiratory rate, bpm
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: body temperature
Temperature, ºС
Time frame: Day 1 - Day 6
Evaluation of concomitant therapy
Number and types of concomitant therapy
Time frame: Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula
Precentage of white blood cells of different types
Time frame: Day 1, Day 6
Laboratory evaluation: hemoglobin
Hemoglobin, g/L
Time frame: Day 1, Day 6
Laboratory evaluation: leukocyte count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: platelet count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: red blood cell count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: hematocrit
Hematocrit, %
Time frame: Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate
mm/h
Time frame: Day 1, Day 6
Laboratory evaluation: blood glucose
mmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: total protein
g/L
Time frame: Day 1, Day 6
Laboratory evaluation: total bilirubin
mcmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: AST
U/L
Time frame: Day 1, Day 6
Laboratory evaluation: ALT
U/L
Time frame: Day 1, Day 6
Laboratory evaluation: creatinine
mcmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: urea
mmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: triglycerides
mmol/L
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 0 - Day 21±1