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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01651663
• Date of registration: 02/07/2012
• Prospective Registration: No
• Primary sponsor: Pharmstandard
• Public title: A Study of Arbidol (Umifenovir) for Treatment and Prophylaxis of Influenza and Common Cold ARBITR
• Scientific title: Double-blind, Randomized, Placebo-controlled Clinical Study Investigating Efficacy and Safety of Arbidol (Umifenovir) in Treatment and Prophylaxis of Influenza and Common Cold.
• Date of first enrolment: September 2011
• Target sample size: 840
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01651663
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Russian Federation

Contacts

• Name: Alexander Denisenko, MD

• Name: Oleg Kiselev, Dr.Biol.Sci.
• Affiliation: Research Instituete of Influenza

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Drug: Arbidol (Umifenovir)

Other: placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

Frequency of emergence of antiviral resistance [Time Frame: Baseline up to 20 days]

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]

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]

Secondary ID(s)

ARB-M1/P01-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors