InfluenzaPhase 4ARBITRNCT01651663
A Study of Arbidol (Umifenovir) for Treatment and Prophylaxis of Influenza and Common Cold
A Phase 4 study testing Arbidol (Umifenovir) in people with Influenza, run by Pharmstandard at 2 sites in Russia.
Trial summary
The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the treatment and Prophylaxis of Influenza and Common Cold Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Arbidol (Umifenovir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- 2 sitesRussia
- Study dates
- Sep 2011to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Not yet recruiting
Research Institute of Influenza
Saint Petersburg, 197376
- Recruiting
Study site
Saratov
About this study
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.
The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the treatment and Prophylaxis of Influenza and Common Cold
Read the 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.
- Conditions
- Influenza
- Being tested
- Arbidol (Umifenovir), placebo
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbidol (Umifenovir)Drug
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
placeboOther
Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
Arbidol (Umifenovir)Drug
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
placeboOther
Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Arbidol (Umifenovir) | Experimental | Not described Receives: Drug: Arbidol (Umifenovir) |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
| Arbidol (Umifenovir) prophylaxis | Experimental | Not described Receives: Drug: Arbidol (Umifenovir) |
| placebo prophylaxis | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo.
Measured: Baseline up to 20 days
Time to alleviation of influenza and common cold clinical symptoms
Measured: Baseline up to 20 days
Number of Adverse Events that are probably or definitely related to Arbidol
Measured: Baseline up to 20 days
Secondary outcomes (4)
Number of clinical complications associated with influenza and common cold among treatment group vs placebo
Measured: Baseline up to 20 days
The time to no detectable influenza virus by culture for the throat and nose swabs, assessed by PCR
Measured: 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
Measured: Baseline up to 20 days
Frequency of emergence of antiviral resistance
Measured: Baseline up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmstandard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oleg Kiselev, Dr.Biol.Sci., Principal investigator, Research Instituete of Influenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651663
- Sponsor's protocol ID
- ARB-M1/P01-11
- Acronym
- ARBITR
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01651663
- Acronym / sponsor ID
- ARBITR / ARB-M1/P01-11
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- PharmstandardIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arbidol (Umifenovir) | Experimental | Drug: Arbidol (Umifenovir) |
| placebo | Placebo comparator | Other: placebo |
| Arbidol (Umifenovir) prophylaxis | Experimental | Drug: Arbidol (Umifenovir) |
| placebo prophylaxis | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbidol (Umifenovir)Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days. | Drug | Arbidol (Umifenovir) |
| placeboArbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days. | Other | placebo |
| 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. | Drug | Arbidol (Umifenovir) prophylaxis |
| placeboMedically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days. | Other | placebo prophylaxis |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg Kiselev, Dr.Biol.Sci. principal investigator
Research Instituete of Influenza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arbidol (Umifenovir) in people with Influenza, run by Pharmstandard at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Denisenko, MD (+7 495 970 00 30, aadenisenko@pharmstd.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of clinical illness among patients with common cold and influenza treated with Arbidol vs placebo. (time frame: Baseline up to 20 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.