Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin®, capsules, 60 mg | Experimental | Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy. |
|
| Placebo | Placebo Comparator | Placebo will be administered once a day for 5 days on top of standard therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin® | Drug | 60 mg/day for 5 days |
| |
| Placebo |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation | Recruiting | Rostov-on-Don | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
1 capsule/day for 5 days |
|
Disappearance of cough; no recurrence of cough in the following days of observation |
| 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 |
| 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 |
| GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation | Recruiting | Tomsk | Russia |
|
| GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation | Recruiting | Yaroslavl | 150000 | Russia |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C539419 | pentanedioic acid imidazolyl ethanamide |
Not provided
Not provided
Not provided