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

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

Arbidol (Umifenovir)

placebo

Arbidol (Umifenovir)

placebo

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Institute of Influenza
Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Arbidol (Umifenovir)

placebo

Arbidol (Umifenovir) prophylaxis

placebo prophylaxis

Arm Description

Outcomes

Primary Outcome Measures

Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo.

Time to alleviation of influenza and common cold clinical symptoms

Number of Adverse Events that are probably or definitely related to Arbidol

Secondary Outcome Measures

Number of clinical complications associated with influenza and common cold among treatment group vs placebo

The time to no detectable influenza virus by culture for the throat and nose swabs, assessed by PCR

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

Frequency of emergence of antiviral resistance

Full Information

NCT ID

NCT01651663

First Posted

July 2, 2012

Last Updated

July 26, 2013

Sponsor

Pharmstandard

1. Study Identification

Unique Protocol Identification Number

NCT01651663

Brief Title

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

Acronym

ARBITR

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 Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmstandard

4. Oversight

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arbidol (Umifenovir)

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Title

Arbidol (Umifenovir) prophylaxis

Arm Type

Experimental

Arm Title

placebo prophylaxis

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Arbidol (Umifenovir)

Intervention Description

Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.

Intervention Type

Drug

Intervention Name(s)

Arbidol (Umifenovir)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo.

Time Frame

Baseline up to 20 days

Title

Time to alleviation of influenza and common cold clinical symptoms

Time Frame

Baseline up to 20 days

Title

Number of Adverse Events that are probably or definitely related to Arbidol

Time Frame

Baseline up to 20 days

Secondary Outcome Measure Information:

Title

Number of clinical complications associated with influenza and common cold among treatment group vs placebo

Time Frame

Baseline up to 20 days

Title

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

Title

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

Title

Frequency of emergence of antiviral resistance

Time Frame

Baseline up to 20 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander Denisenko, MD

Phone

+7 495 970 00 30

aadenisenko@pharmstd.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Dmitriy Davydov, MD

Phone

+7 495 970 00 30

dgdavydov@pharmstd.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oleg Kiselev, Dr.Biol.Sci.

Organizational Affiliation

Research Instituete of Influenza

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Institute of Influenza

City

Sankt-Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Individual Site Status

Not yet recruiting

City

Saratov

Country

Russian Federation

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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