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

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

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

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Drug: Arbidol (Umifenovir); Drug: Arbidol (Umifenovir); Other: placebo; Other: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 840
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexander Denisenko, MD; Phone Number: +7 495 970 00 30; Email: aadenisenko@pharmstd.ru
• Study Contact Backup: Name: Dmitriy Davydov, MD; Phone Number: +7 495 970 00 30; Email: dgdavydov@pharmstd.ru

Study Locations

• Russian Federation
  • Sankt-Petersburg, Russian Federation, 197376
    • Not yet recruiting
    • Research Institute of Influenza
  • Saratov, Russian Federation
    • Recruiting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo; Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 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.
Experimental: Arbidol (Umifenovir)	Drug: Arbidol (Umifenovir); 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.
Experimental: Arbidol (Umifenovir) prophylaxis	Drug: Arbidol (Umifenovir); 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.
Placebo Comparator: placebo prophylaxis	Other: placebo; Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Pharmstandard
• Investigators: Principal Investigator: Oleg Kiselev, Dr.Biol.Sci., Research Instituete of Influenza

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Orthomyxoviridae Infections; Influenza, Human; Common Cold
• Other Study ID Numbers: ARB-M1/P01-11