A Study of Arbidol (Umifenovir) for Treatment and Prophylaxis of Influenza and Common Cold (ARBITR)
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ClinicalTrials.gov Identifier: NCT01651663 |
Recruitment Status : Unknown
Verified July 2013 by Pharmstandard.
Recruitment status was: Recruiting
First Posted : July 27, 2012
Last Update Posted : July 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Drug: Arbidol (Umifenovir) Other: placebo | Phase 4 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651663
Contact: Alexander Denisenko, MD | +7 495 970 00 30 | aadenisenko@pharmstd.ru | |
Contact: Dmitriy Davydov, MD | +7 495 970 00 30 | dgdavydov@pharmstd.ru |
Russian Federation | |
Research Institute of Influenza | Not yet recruiting |
Sankt-Petersburg, Russian Federation, 197376 | |
Recruiting | |
Saratov, Russian Federation |
Principal Investigator: | Oleg Kiselev, Dr.Biol.Sci. | Research Instituete of Influenza |
Responsible Party: | Pharmstandard |
ClinicalTrials.gov Identifier: | NCT01651663 |
Other Study ID Numbers: |
ARB-M1/P01-11 |
First Posted: | July 27, 2012 Key Record Dates |
Last Update Posted: | July 29, 2013 |
Last Verified: | July 2013 |
Influenza |
Influenza, Human Common Cold Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases Picornaviridae Infections |