Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.

• Status: Completed
• Trial end date: 2010-05-15
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule.

Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug.

The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system.

Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joint Stock Company "Farmak"

Criteria

Inclusion Criteria:

• Patients aged between 18 to 60 years

• Patients with ARVI, including influenza, starting not later than for 1 day prior to inclusion in the study:

• The body temperature measured axillary above 37.2 °C

• Presence of one of the signs of respiratory disease (runny nose, cough, pain / tickling in the throat)

• Presence of one of the systemic symptoms (weakness, myalgia, headache , chills, sweating)

• Provide written informed consent

• Ability to understand the nature of the study and provide written informed consent in accordance with Good Clinical Practice (GCP) and local law

Exclusion Criteria:

• Age over 60 years and under 18 years old

• Presence of allergic reactions

• Intolerance to NSAIDs and iodine-containing drugs

• Hypersensitivity to the components of the drug

• Mental illness that impedes compliance with the research procedure

• Pregnancy or breast-feeding

• Presence of acute, clinically significant respiratory and cardio vascular insufficiency, functional disorders of liver, kidney, digestive tract (ulcer disease) determined at physical examination or by laboratory screening tests

• Presence of congenital defects or serious chronic disease of the lungs, kidneys, cardiovascular system, nervous system, metabolic disorders, psychiatric disorders, confirmed by patients history or during initial examination

• The use of preparations of blood cytokine immunoglobulin in for 3 months prior to the study

• Chronic use of alcohol and / or drugs

• Presence or history of cancer diseases, HIV, hepatitis B and C

• Application of immunosuppressive or immunomodulatory drugs for 6-months prior to the study

• Women of child-bearing potential and who do not use acceptable measure of contraception or do not plan to use those throughout the study

• Any clinical condition that, according to the investigator, will not allow to safely carry out the protocol and take the studied drugs without risk to health

• Patients receiving antiviral therapy,

• Participation in other clinical trials at the present time or during the last 3 months.