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The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.
Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin | Experimental | Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days |
|
| Placebo | Placebo Comparator | Placebo capsule identical in appearance to Ingavirin capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of fever | Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up). | 7 ± 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution / alleviation of intoxication symptoms | Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs. | 7 ± 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | All adverse events recorded and analysed, to compare incidence rate with one of placebo. Complete blood count test performed at the beginning and at the end of the study. Vital signs taken and recorded at each visit throughout the study, usually every day for 7 ± 1 days. | Through study completion, an average of 8 days |
Inclusion Criteria:
Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:
Laboratory confirmation of viral origin of the disease
Uncomplicated influenza and other acute respiratory viral infections
Interval between onset of symptoms and enrollment to the study not more than 48 hours
Have read, understood and signed an informed consent form
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 |
|---|---|---|---|---|---|---|
| State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development" | Chelyabinsk | 454092 | Russia |
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Double Blind
| Drug |
|
| Time to resolution / alleviation of catarrhal symptoms | Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration. | 7 ± 1 days |
| N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology | Moscow | 123098 | Russia |
| State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1" | Novosibirsk | Russia |
| North-western State Medical University named after I.I.Mechnikov | Saint Petersburg | 195067 | Russia |
| Saratov State Medical University named after V. I. Razumovsky | Saratov | 410012 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation | Vladivostok | 690002 | Russia |
| Volgograd State Medical University | Volgograd | 400131 | Russia |
| Yaroslavl State Medical University | Yaroslavl | 150000 | Russia |
| Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation | Yekaterinburg | 620028 | Russia |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| 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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