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| Name | Class |
|---|---|
| Atlant Clinical Ltd. | OTHER |
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The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin | Experimental | Ingavirin (Imidazolyl ethanamide pentandioic acid), capsules 30 mg daily for 5 days. The contents of one capsule of Ingavirin, capsules 30 mg should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. |
|
| Placebo | Placebo Comparator | Placebo, capsules daily for 5 days. The contents of one capsule of placebo should be dissolved in 50-70 ml of water at room temperature or apple juice at room temperature with mandatory stirring for 20 seconds and administered orally 1 time a day regardless of the meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imidazolyl ethanamide pentandioic acid | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to decrease in the Influenza and Other ARVI Severity Scale score to 2 points with no more than 1 point at individual subscales and normalization of body temperature | Temperature normalization means establishment of body temperature below 37 ° C without raising thereafter till 5 days after the treatment start. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to decrease in the Influenza and Other ARVI Severity Scale score to 0 points | 5 days | |
| Average score at the Influenza and Other ARVI Severity Scale by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment | Within 6 days from the start of treatment |
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Inclusion Criteria:
The informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study.
Male and female patients aged 3-6.
Patients with moderate course of influenza or other acute respiratory viral infections.
Patients with clinically diagnosed influenza or other ARVI based on the body temperature > 37,5 ° C, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms:
Established diagnosis J06.9, J10, J11, in accordance with ICD-10.
Uncomplicated course of influenza and other ARVI.
Interval between onset of symptoms and enrollment to the study of not more than 36 hours.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Zakharova, MD, PhD | Valenta Pharm JSC | Study Director |
| Yuriy V. Lobzin, MD, PhD | Scientific Research Institute of Children's Infections, Federal Biomedical Agency, Saint-Petersburg, Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation | Kazan' | Russia | ||||
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| Drug |
|
| The area under the "Influenza and Other ARVI Severity Scale score - time" curve by the 5th day after the start of treatment | 5 days |
| Time to normalization of body temperature from the start of treatment, measured in hours | Temperature normalization means establishment of body temperature below 37°C without raising thereafter till 5 days after the treatment start | 5 days |
| The average body temperature by the1st, 2nd, 3rd, 4th and 5th days after the start of treatment | 5 days |
| The percentage of patients with normalization of body temperature by the 1st, 2nd, 3rd, 4th and 5th days after the start of treatment | 5 days |
| The area under the "temperature-time" curve by the 5th day after the start of treatment | 5 days |
| The percentage of patients with complications of influenza and other ARVI developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment | 14 days |
| The percentage of patients with severe complications of influenza and other ARVI that have developed over the period from the 1st to the 6th and from the 1st to 14th day after the start of treatment | 14 days |
| Time to onset of complications of influenza and other ARVI from the start of treatment | 14 days |
| Assessment of adverse events (AEs) and serious adverse events (SAEs) | Assessment of adverse events (AEs) and serious adverse events (SAEs) by means of -
| 14 days |
| GBOU VPO "Krasnoyarsk State Medical University n.a.n V.F. Voyno-Yasenetskogo" of Ministry of Health of Russian Federation |
| Krasnoyarsk |
| Russia |
| FGBU "Scientific center of children health" of the Ministry of Health of Russian Federation | Moscow | Russia |
| I.M. Sechenov First Moscow State Medical University | Moscow | Russia |
| Moscow Budgetary Public Health Facility "Infectious clinical hospital #1" of Moscow City Health Department | Moscow | Russia |
| GBOU VPO "Novosibirsk State Medical University of Ministry of Health of Russian Federation" | Novosibirsk | Russia |
| Children's city outpatients clinic № 5 | Perm | Russia |
| Children's city outpatients clinic № 4 | Rostov-on-Don | Russia |
| GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation | Rostov-on-Don | Russia |
| FGBU "Scientific Research Institute of Children's Infections, Federal Biomedical Agency" | Saint Petersburg | Russia |
| FGBOU VPO "Mordov State University n.a. N.P. Ogarev" | Saransk | Russia |
| GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation | Tomsk | Russia |
| GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
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| ID | Term |
|---|---|
| C539419 | pentanedioic acid imidazolyl ethanamide |
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