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The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the treatment and Prophylaxis of Influenza and Common Cold
Influenza virus infections result in major health and economic burdens worldwide. The World Health Organization estimates that the average global burden of interpandemic influenza is approximately 1 billion cases of influenza, from 3 to 5 million cases of severe illness, and from 300 000 to 500 000 deaths annually. Arbidol (Umifenovir) is currently licensed for the treatment and prevention of influenza in Russian Federation. Arbidol (Umifenovir) has a direct antiviral effect. Arbidol (Umifenovir) belongs to fusion inhibitors; it interacts with the virus hemagglutinin and thus prevents fusion of the viral envelope with cell membranes. The aim of the study is to obtain additional data on safety and therapeutic efficacy of investigational product Arbidol (Umifenovir) in patients with a diagnosis of influenza and common cold. Furthermore, study of viral resistance in patients with seasonal influenza infection treated with Arbidol (Umifenovir) will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arbidol (Umifenovir) | Experimental |
| |
| placebo | Placebo Comparator |
| |
| Arbidol (Umifenovir) prophylaxis | Experimental |
| |
| placebo prophylaxis | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arbidol (Umifenovir) | Drug | Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo. | Baseline up to 20 days | |
| Time to alleviation of influenza and common cold clinical symptoms | Baseline up to 20 days | |
| Number of Adverse Events that are probably or definitely related to Arbidol | Baseline up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical complications associated with influenza and common cold among treatment group vs placebo | Baseline up to 20 days | |
| The time to no detectable influenza virus by culture for the throat and nose swabs, assessed by PCR | Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Denisenko, MD | Contact | +7 495 970 00 30 | aadenisenko@pharmstd.ru | |
| Dmitriy Davydov, MD | Contact | +7 495 970 00 30 | dgdavydov@pharmstd.ru |
| Name | Affiliation | Role |
|---|---|---|
| Oleg Kiselev, Dr.Biol.Sci. | Research Instituete of Influenza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Influenza | Not yet recruiting | Saint Petersburg | 197376 | Russia | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 20, 2021 | |
| Reset | Aug 12, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2021 | Aug 12, 2021 |
| 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 |
|---|---|
| C086979 | umifenovir |
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| placebo | Other | Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days. |
|
| Arbidol (Umifenovir) | Drug | Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days. |
|
| placebo | Other | Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days. |
|
| Occurrence of influenza and common cold among participants in prophylaxis group diagnosed by physician according to history and physical examination and laboratory tests if was necessary | Baseline up to 20 days |
| Frequency of emergence of antiviral resistance | Baseline up to 20 days |
| Recruiting |
| Saratov |
| Russia |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |