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

Influenza Clinical Trial

— ARBITR  

Official title:

Double-blind, Randomized, Placebo-controlled Clinical Study Investigating Efficacy and Safety of Arbidol (Umifenovir) in Treatment and Prophylaxis of Influenza and Common Cold.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01651663
• Other study ID #: ARB-M1/P01-11
• Status: Recruiting
• Phase: Phase 4
• First received: July 2, 2012
• Last updated: July 26, 2013
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2013
• Source: Pharmstandard
• Contact: Alexander Denisenko, MD
• Phone: +7 495 970 00 30
• Email: aadenisenko[@]pharmstd.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Influenza
• Influenza, Human

Intervention

Drug:
• Arbidol (Umifenovir)
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.

Other:
• placebo
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.

Drug:
• Arbidol (Umifenovir)
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.

Other:
• placebo
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.

Locations

Country	Name	City	State
Russian Federation	Research Institute of Influenza	Sankt-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Pharmstandard

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo.		Baseline up to 20 days	No
Primary	Time to alleviation of influenza and common cold clinical symptoms		Baseline up to 20 days	No
Primary	Number of Adverse Events that are probably or definitely related to Arbidol		Baseline up to 20 days	Yes
Secondary	Number of clinical complications associated with influenza and common cold among treatment group vs placebo		Baseline up to 20 days	No
Secondary	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	No
Secondary	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	No
Secondary	Frequency of emergence of antiviral resistance		Baseline up to 20 days	No