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

NCT04682444 | Completed Phase 2 Results

• 1 other identifier: AM-STP-2-2008
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Acute Respiratory Viral Infections; Human Influenza

Keywords

Viral infections; Amizon; Enisamium iodide; Influenza

Outcome Measures

Primary Outcomes (3)

• Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall

  Count of participants WITHOUT objective symptoms -- overall. Objective symptoms of acute respiratory viral infection (ARVI), including influenza, were monitored: fever, pharyngeal hyperemia, rhinitis, arterial blood pressure, enlarged lymph nodes, auscultation findings for lung and heart. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. A score system used to assess participants' health. A higher score implies worse outcome. Objective symptoms scores were: normal or abnormal blood pressure: 0 or 4 score points; lung auscultation: 0 points; vesicular breath sound and wheezing or crepitation 2 or 4 points, respectively; clear and rhythmic heart sounds -- each 0 points; noisy and arrhythmic heart sounds -- each 2 score points.

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Number of Participants -- Days Without Routine Activities -- Summary

  Count of participants who had days WITHOUT routine activities. Disability to perform routine tasks and activities were reported by the participants to the investigator at each study visit.

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Number of Participants -- Viral Antigens -- Overall

  Viral antigens that were evaluated: adenovirus, corona virus, influenza A, influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was based on the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. Results represent the count of participants who did NOT have detectable viral antigens.

  Day 0 (baseline), 3, 7.

Secondary Outcomes (24)

• Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough

  Day 0 (baseline), 3, 7, 14.

• Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature

  Day 0 (baseline), 3, 7, 14.

Study Arms (2)

Group 1 - Active Treatment - Amizon

EXPERIMENTAL

Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (as 2 tablets, each tablet containing 250 mg enisamium iodide) after a meal, 3 times a day, for 7 days.

Drug: Enisamium Iodide

Group 2 - Placebo

PLACEBO COMPARATOR

Patient who were randomized into Group 2 ingested placebo tablets 500 mg (2 tablets), after a meal 3 times a day, for 7 days.

Drug: Placebo

Interventions

Enisamium Iodide DRUG

Patients ingested Amizon tablets without chewing, after meal, as follows: 2 tablets (total dose 500 mg) 3 times a day, for 7 days. Each tablet contains 250 mg of Nmethyl-4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide).

Also known as: Amizon

Group 1 - Active Treatment - Amizon

Placebo DRUG

Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.

Group 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 to 60 years
• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Related Publications (1)

• Te Velthuis AJW, Zubkova TG, Shaw M, Mehle A, Boltz D, Gmeinwieser N, Stammer H, Milde J, Muller L, Margitich V. Enisamium Reduces Influenza Virus Shedding and Improves Patient Recovery by Inhibiting Viral RNA Polymerase Activity. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02605-20. doi: 10.1128/AAC.02605-20. Print 2021 Mar 18.

  PMID: 33558285 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

enisamium iodide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Enquiry Manager
• Organization: Farmak

Farmak-Clinical-Affairs@regenold.com

+ 38 (067) 464-28-27

Study Officials

• Ekatarina A. Okhapkina

  Smorodintsev Research Institute of Influenza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) Matching placebo tablet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: April 13, 2009
• Primary Completion: January 15, 2010
• Study Completion: January 15, 2010
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share