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The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 13-17 years old patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin | Experimental | Broad spectrum antiviral drug |
|
| Placebo oral capsule | Placebo Comparator | Placebo capsule identical in appearance to Ingavirin capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin | Drug | Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of fever | Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС) | 7 ± 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of intoxication symptoms | Time from the start of study treatment to resolution of all intoxication symptoms. | 7 ± 1 days |
| Time to resolution of catarrhal symptoms | Time from the start of study treatment to resolution of all catarrhal symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection | Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days) | 7 ± 1 days and 21 ± 1 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Zakharova, MD, PhD | Valenta Pharm JSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation | Kazan' | 420012 | Russia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | A.A.Shul'dyakov, E.P.Lyapina, V.I.Kuznetsov, N.I.Zryachkin, I.G.Sitnikov, O.A.Perminova, V.A.Anokhin4, G.R.Fatkullina. New possibilities in therapy of acute respiratory viral infections in children. Vopr. Prakt. Pediatrii. 2015 vol10 n5 pp21-28. Russian |
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| Placebo oral capsule | Drug | Placebo, capsules daily for 5 days. |
|
| 7 ± 1 days |
| Time to resolution/alleviation of cough | Time from the start of study treatment to resolution/alleviation of cough | 7 ± 1 days |
| City Pediatric Outpatient Clinic number 5 |
| Perm |
| 614066 |
| Russia |
| Research Institute of Influenza, Ministry of Healthcare of Russian Federation | Saint Petersburg | 197376 | Russia |
| Saratov State Medical University named after V. I. Razumovsky | Saratov | 410012 | Russia |
| GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation | Yaroslavl | 150000 | Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
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| ID | Term |
|---|---|
| C539419 | pentanedioic acid imidazolyl ethanamide |
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