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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 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin | Experimental |
| |
| Placebo oral capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin | Drug | Ingavirin 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 resolution of fever | Proportion of subjects with resolution of fever by 1st, 2nd, 3rd, 4th and 5th days of treatment | 7 ± 1 |
| Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection |
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 | I.M. Farber, N.A. Geppe, D.V. Reikhart, V.E. Nebolsin, V.S. Arnautov, A.A. Globenko. Therapy for influenza and acute respiratory viral infection in young and middle-aged schoolchildren: Effect of Ingavirin® on intoxication, fever, and catarrhal syndromes. Ros Vestn Perinatol Pediat 2016; 2:115-120. Russian. | ||
| Result | N.A. Geppe, E.D. Teplyakova, A.A. Shuldyakov, E.P. Lyapina, O.A. Perminova, G.P. Martynova, I.G. Sitnikov, V.A. Anohin, G.R. Fatkullina, V.V. Romanenko, A.A. Savisko, E.G. Kondyurina, L.A. Balykova. Innovations in pediatrics: the optimal clinical effect In acute respiratory viral infections treatment In children with complex action drug. Pediatry 2016, 2(95), 97-103. Russian. |
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| Placebo oral capsule | Drug | Placebo, capsules daily for 5 days. |
|
| 7 ± 1 days |
Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days) |
| 21 ± 1 |
| Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky |
| Krasnoyarsk |
| 660022 |
| Russia |
| I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia |
| Novosibirsk State Medical University | Novosibirsk | 630091 | Russia |
| City Pediatric Outpatient Clinic number 5 | Perm | 614066 | Russia |
| Rostov State Medical University | Rostov-on-Don | 344022 | Russia |
| Pediatrics outpatient clinic number 4 of Rostov-na-Donu | Rostov-on-Don | 344065 | Russia |
| Ogarev Mordovia State University | Saransk | 430005 | 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 |
| Pediatrician City Hospital number 11 | Yekaterinburg | 62028 | 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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