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

• ClinicalTrials.gov Identifier: NCT01651663
• Recruitment Status: Unknown
• First Posted: July 27, 2012
• Last Update Posted: July 29, 2013
• Sponsor: Pharmstandard
• Information provided by (Responsible Party): Pharmstandard

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Influenza	Drug: Arbidol (Umifenovir); Other: placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 840 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Study Start Date: September 2011
• Estimated Primary Completion Date: June 2015
• Estimated Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
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.
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.
Experimental: Arbidol (Umifenovir) prophylaxis	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; Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.

Outcome Measures

Primary Outcome Measures :

1. Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo. [ Time Frame: Baseline up to 20 days ]
2. Time to alleviation of influenza and common cold clinical symptoms [ Time Frame: Baseline up to 20 days ]
3. Number of Adverse Events that are probably or definitely related to Arbidol [ Time Frame: Baseline up to 20 days ]

Secondary Outcome Measures :

1. Number of clinical complications associated with influenza and common cold among treatment group vs placebo [ Time Frame: Baseline up to 20 days ]
2. 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 ]
3. 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 ]
4. Frequency of emergence of antiviral resistance [ Time Frame: Baseline up to 20 days ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Alexander Denisenko, MD; +7 495 970 00 30; aadenisenko@pharmstd.ru

Contact: Dmitriy Davydov, MD; +7 495 970 00 30; dgdavydov@pharmstd.ru

Locations

Russian Federation

Research Institute of Influenza; Not yet recruiting

Sankt-Petersburg, Russian Federation, 197376

Recruiting

Saratov, Russian Federation

Sponsors and Collaborators

Pharmstandard

Investigators

• Principal Investigator: Oleg Kiselev, Dr.Biol.Sci.; Research Instituete of Influenza

More Information

• Responsible Party: Pharmstandard
• ClinicalTrials.gov Identifier: NCT01651663
• Other Study ID Numbers: ARB-M1/P01-11
• First Posted: July 27, 2012
• Last Update Posted: July 29, 2013
• Last Verified: July 2013

Keywords provided by Pharmstandard:

Influenza

Additional relevant MeSH terms:

Influenza, Human; Common Cold; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections