A Phase 4 interventional study of Arbidol (Umifenovir) and placebo in Influenza, sponsored by Pharmstandard. Status unknown at 2 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-29.
Sponsored by Pharmstandard · Phase 4, Interventional, and Treatment
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 840 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →This is the only study on the registry with Pharmstandard as lead sponsor.
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Exclusion Criteria:
Drug: Arbidol (Umifenovir)
Other: placebo
Drug: Arbidol (Umifenovir)
Other: placebo
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo.
Time frame: Baseline up to 20 days
Time to alleviation of influenza and common cold clinical symptoms
Time frame: Baseline up to 20 days
Number of Adverse Events that are probably or definitely related to Arbidol
Time frame: Baseline up to 20 days
Number of clinical complications associated with influenza and common cold among treatment group vs placebo
Time frame: Baseline up to 20 days
The time to no detectable influenza virus by culture for the throat and nose swabs, assessed by PCR
Time frame: Day 3, Day 4, Day 5, Day 6, Day 7, Day 8
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
Time frame: Baseline up to 20 days
Frequency of emergence of antiviral resistance
Time frame: Baseline up to 20 days
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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