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The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections
The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.
The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.
Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.
Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.
The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.
Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin | Experimental | Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days |
|
| Placebo | Placebo Comparator | Placebo oral capsule, once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) | Drug | Broad-spectrum antiviral agent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups | To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)*100% then divided by incidence in placebo group. | Through study completion, an average of 37 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri | Through study completion, an average of 37 days |
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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 |
|---|---|---|---|---|---|---|
| Research Institute of Influenza | Saint Petersburg | 197376 | Russia | |||
| Saratov State Medical University named after V. I. Razumovsky |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24432596 | Result | Shul'diakov AA, Liapina EP, Kuznetsov VI. [Current principles in the chemoprophylaxis of acute respiratory viral infections]. Ter Arkh. 2013;85(11):27-33. Russian. |
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| Placebo oral capsule |
| Drug |
Placebo capsule to match Ingavirin capsule |
|
| Saratov |
| 410012 |
| Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| D014777 | Virus Diseases |
| 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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