A Study of Arbidol (Umifenovir) for Treatment and Prophylaxis of Influenza and Common Cold (ARBITR)

Pharmstandard

Status and phase: Unknown; Phase 4

Conditions: Influenza

Treatments: Other: placebo; Drug: Arbidol (Umifenovir)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651663

ARB-M1/P01-11

Details and patient eligibility

About

The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the treatment and Prophylaxis of Influenza and Common Cold

Full description

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Patient Information and Informed Consent Form.
• Male and female patients from 18 to 65 years.
• Out-patients with uncomplicated* form of common cold or influenza.
• Illness duration no more than 36 hours.
• At least one episode of body temperature 38°C or higher during the past 36 hours.
• Presence of at least one of the following symptoms: Headache, fatigue/malaise, pain/aches in muscles, fever/chills.
• Patient's ability to adequately cooperate.

Exclusion criteria

• A history of allergic reactions to the investigational drug Arbidol (Umifenovir) or hypersensitivity to the drug.
• Illness duration over 36 hours.
• Any complications of influenza/common cold or signs of severe or progressive disease* at the moment of selection for participation in the study.
• A history of influenza vaccination carried out in the last 12 months.
• Evidence of severe hematological, immunological, pulmonary, urogenital, gastrointestinal, hepatic, renal, endocrine, metabolic, psychiatric, dermatovenereological diseases, collagenoses, nutritional disorders, which are known from patient's history, physical examination or laboratory tests, that may limit the patient from participating in the study or which may affect the results of the study.
• Participation in other clinical studies in the past 4 months.
• Common cold or other infection during last 4 weeks before enrollment.
• Administration of Arbidol (Umifenovir) during last 4 weeks before the onset of disease.
• Administration of immunomodulators, interferon inducers, homeopathic, hormonal, antiviral and antibacterial drugs during last 4 weeks before the selection for participation in the study.
• Alcohol or substance abuse.
• Hospitalization at the moment of selection for participation in the study.
• Pregnant or lactating women.
• Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede the patient's participation in the study or affect the study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 4 patient groups, including a placebo group

Arbidol (Umifenovir)

Experimental group

Treatment:

Drug: Arbidol (Umifenovir)

Drug: Arbidol (Umifenovir)

placebo

Placebo Comparator group

Treatment:

Other: placebo

Other: placebo

Arbidol (Umifenovir) prophylaxis

Experimental group

Treatment:

Drug: Arbidol (Umifenovir)

Drug: Arbidol (Umifenovir)

placebo prophylaxis

Placebo Comparator group

Treatment:

Other: placebo

Other: placebo