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Search / Trial NCT01651663

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

Launched by PHARMSTANDARD · Jul 24, 2012

Trial Information

Current as of May 01, 2025

Unknown status

Keywords

Influenza

ClinConnect Summary

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 fusio...

Gender

ALL

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.

About Pharmstandard

Pharmstandard is a leading pharmaceutical company based in Russia, dedicated to the development, manufacturing, and commercialization of high-quality generic and innovative medicines. With a strong focus on enhancing patient care and improving health outcomes, Pharmstandard invests heavily in research and development, aiming to expand its portfolio across various therapeutic areas, including oncology, cardiology, and neurology. The company adheres to stringent international standards of quality and regulatory compliance, ensuring that its products meet the highest safety and efficacy benchmarks. Through strategic partnerships and clinical trials, Pharmstandard is committed to advancing medical science and delivering accessible healthcare solutions to patients both domestically and globally.

Locations

Saratov, , Russian Federation

Sankt Petersburg, , Russian Federation

Patients applied

0 patients applied

Trial Officials

Oleg Kiselev, Dr.Biol.Sci.

Principal Investigator

Research Instituete of Influenza

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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