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Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycloferon | Experimental | Intake of Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8. |
|
| Placebo | Placebo Comparator | Intake of Placebo, 4 tablets per day, on days 1, 2, 4, 6 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cycloferon | Drug | Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of influenza/other acute respiratory viral infection in the study groups | the proportion of subjects with clinically manifest and laboratory confirmed influenza or other acute respiratory viral infection, developed within days 1-14 of the study. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana V Kharitonova, MD PhD | STPF POLYSAN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center for Eco-safety, Ltd. | Saint Petersburg | 196143 | Russia | |||
| City Outpatient Clinic #117 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C026430 | 10-carboxymethyl-9-acridanone |
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Double-blind, placebo-controlled, randomized, two-parallel group comparative study
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Randomization is performed using the Internet Interactive Response System (IWRS) before the start of the drug dosing period. During the randomization procedure, the investigator, after assessing whether the subject meets the inclusion criteria and the absence of non-inclusion criteria, will contact IWRS, the system will record the fact that the subject has been randomized and will automatically report the package number of the drug that must be given to the subject.
The study drug CYCLOFERON®, enteric-coated tablets, 150 mg (NTFF POLYSAN LLC, Russia), is supplied in the form of enteric-coated tablets, 150 mg. 10 tablets in a blister pack, 5 blister packs in a cardboard box.
The reference drug PLACEBO, enteric-coated tablets, 150 mg (NTFF POLYSAN LLC, Russia), is supplied in the form of enteric-coated tablets, 150 mg. 10 tablets in a blister pack, 5 blister packs in a cardboard box.
| Placebo | Drug | Placebo tablets, 4 tablets per day on days 1, 2, 4, 6 and 8 |
|
| Saint Petersburg |
| Russia |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |