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.
1 other identifier
interventional
840
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 29, 2013
July 1, 2013
3.8 years
July 2, 2012
July 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Study Arms (4)
Arbidol (Umifenovir)
EXPERIMENTALplacebo
PLACEBO COMPARATORArbidol (Umifenovir) prophylaxis
EXPERIMENTALplacebo prophylaxis
PLACEBO COMPARATORInterventions
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmstandardlead
Study Sites (2)
Research Institute of Influenza
Saint Petersburg, 197376, Russia
Unknown Facility
Saratov, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oleg Kiselev, Dr.Biol.Sci.
Research Instituete of Influenza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2012
First Posted
July 27, 2012
Study Start
September 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 29, 2013
Record last verified: 2013-07