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

Primary Purpose

Acute Respiratory Viral Infections, Human Influenza

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Enisamium Iodide
Placebo
Sponsored by
Joint Stock Company "Farmak"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Viral Infections focused on measuring Viral infections, Amizon, Enisamium iodide, Influenza

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group 1 - Active Treatment

    Group 2 - Placebo

    Arm Description

    Patient who were randomized into Group 1 ingested Amizon tablets 0.5 g (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 0.25 g of enisamium iodide.

    Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 0.5 g (2 tablets), 3 times a day, for 7 days.

    Outcomes

    Primary Outcome Measures

    Efficacy - Clinical improvement from Day 3 after therapy start
    Evaluate the number of patients in the treatment and the placebo groups regarding clinical improvement from Day 3 after therapy start. Clinical improvement was assessed by the investigator from scores of objective and subjective data, relating to the severity of clinical symptoms of ARVI, including influenza. Objective symptoms were assessed using the following score system: normal or abnormal blood pressure was counted 0 or 4 score points; lung auscultation was counted 0 for vesicular breath sound and wheezing or crepitation were scored 2 or 4 points, respectively; clear and rhythmic heart sounds were each scored 0 points, whereas noisy and arrhythmic heart sounds were scored 2 points each. The subjective symptoms were assessed using a 4-point Likert scale, ranging from 1 (absent) to 4 (severe).

    Secondary Outcome Measures

    Efficacy - Time of disappearance of respiratory tract affection symptoms
    Evaluate the time of disappearance of respiratory tract symptoms (rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis, cough). Evaluate the general state of health, condition of cutaneous coverings, oral mucosa and tonsils, peripheral lymph nodes, abdominal cavity organs, nervous and musculoskeletal system, lung and heart percussion and auscultation data were assessed. Evaluate the intensity and duration of the disease symptoms: temperature response, catarrhal events in nasopharynx and other respiratory tract parts. Clinical improvement was assessed by the visit day on which the symptoms were absent (score 1 on the Likert scale, as described for Outcome 1).
    Efficacy - Body temperature normalization
    Monitor body temperature.
    Efficacy - General symptoms of ARVI including influenza
    Time of disappearance of general symptoms -- ARVI, including influenza. Time of disappearance of general symptoms relating to the respiratory tract, including weakness, headache, myalgia, chills, sore throat, and cough.
    Efficacy - Viral antigens
    Viral antigens evaluated: influenza A and B, respiratory syncytial virus, adenovirus, parainfluenza virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence testing methods. Efficacy assessment: evaluate viral antigen levels at the end of treatment (Day 7) versus the baseline data (Day 0) and compare with the placebo group.
    Safety - Adverse events
    Adverse events occurring during the study were recorded daily by the patients into a patient dairy (Day 0 to Day 14). Clinically relevant laboratory parameters changes outside the normal range were also considered as adverse events. The relationship of the adverse events to the intake of the investigational drug assessed by the investigator.
    Safety - Laboratory parameters - Immune status
    Assessment of the immune status was performed by evaluating the concentration in blood serum of interferon [IFN]-alpha and IFN-gamma, immunoglobulin A, immunoglobulin M, immunoglobulin G. Determination of immunoglobulins А, М, G was performed by turbidimetry. Determination of interferon-alpha and interferon-gamma in human blood serum was carried out using flow cytometer.

    Full Information

    First Posted
    December 17, 2020
    Last Updated
    December 22, 2020
    Sponsor
    Joint Stock Company "Farmak"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04682444
    Brief Title
    Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
    Official Title
    A Prospective Single-blind Comparative Clinical Study of Efficacy and Safety of Amizon 0.25 g Tablets, Manufactured by Farmak JSC, in Patients With ARVI, Including Influenza.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 13, 2009 (Actual)
    Primary Completion Date
    January 28, 2010 (Actual)
    Study Completion Date
    May 15, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Joint Stock Company "Farmak"

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are able to protect about 80% of otherwise healthy children and adults. However, to develop vaccines against the emerging new pandemic strain of the influenza virus and produce them in the necessary amounts requires at least 6 months. During such interim periods, sufficient protection of the population is essential by effective measures for treatment and prevention of influenza. This randomized, single-blind, clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide) compared with placebo, for the treatment of patients with ARVI, including influenza. Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication. The study design was: randomised, single-blind, 2 parallel groups. Adult patients (18-60 y) with symptoms of ARVI, including influenza took either Amizon tablets (active ingredient enisamium iodide) for 7 days; in the control group patients took placebo tablets for 7 days. Study visits occurred on Day 0 (screening, examination, check inclusion/exclusion criteria, enrollment, randomization, and first intake of study drug); further study visits were on Day 3, Day 7, and Day 14. The effect of treatment was assessed by questioning the patients regarding ARVI and influenza symptoms that included pain, headache, general weakness, sore throat, pain in the joints, fatigue, runny and itchy nose. The severity of symptoms was recorded using a 4-point Likert scale. Further evaluation of the treatment was performed by measuring the vitals signs, laboratory tests that included blood and urine analysis, biochemical analysis, as well as assessing the immune status (including measuring the absolute lymphocytes count, and evaluating the relative concentration of interferon (IFN)-alpha and IFN-gamma, and immunoglobulins (IgA, IgM, and IgG).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Viral Infections, Human Influenza
    Keywords
    Viral infections, Amizon, Enisamium iodide, Influenza

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant, Outcomes Assessor) Matching placebo tablet.
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 - Active Treatment
    Arm Type
    Experimental
    Arm Description
    Patient who were randomized into Group 1 ingested Amizon tablets 0.5 g (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 0.25 g of enisamium iodide.
    Arm Title
    Group 2 - Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 0.5 g (2 tablets), 3 times a day, for 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Enisamium Iodide
    Other Intervention Name(s)
    Amizon
    Intervention Description
    Patients ingested Amizon tablets after meal without chewing as follows: 2 tablets (total dose 0.5 g) 3 times a day, for 7 days. Each tablet contains 0.25 g of Nmethyl- 4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients ingested placebo tablets after meal without chewing in the dose 0.5 g (2 tablets), 3 times a day, for 7 days.
    Primary Outcome Measure Information:
    Title
    Efficacy - Clinical improvement from Day 3 after therapy start
    Description
    Evaluate the number of patients in the treatment and the placebo groups regarding clinical improvement from Day 3 after therapy start. Clinical improvement was assessed by the investigator from scores of objective and subjective data, relating to the severity of clinical symptoms of ARVI, including influenza. Objective symptoms were assessed using the following score system: normal or abnormal blood pressure was counted 0 or 4 score points; lung auscultation was counted 0 for vesicular breath sound and wheezing or crepitation were scored 2 or 4 points, respectively; clear and rhythmic heart sounds were each scored 0 points, whereas noisy and arrhythmic heart sounds were scored 2 points each. The subjective symptoms were assessed using a 4-point Likert scale, ranging from 1 (absent) to 4 (severe).
    Time Frame
    Day 0, 3, 7, 14
    Secondary Outcome Measure Information:
    Title
    Efficacy - Time of disappearance of respiratory tract affection symptoms
    Description
    Evaluate the time of disappearance of respiratory tract symptoms (rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis, cough). Evaluate the general state of health, condition of cutaneous coverings, oral mucosa and tonsils, peripheral lymph nodes, abdominal cavity organs, nervous and musculoskeletal system, lung and heart percussion and auscultation data were assessed. Evaluate the intensity and duration of the disease symptoms: temperature response, catarrhal events in nasopharynx and other respiratory tract parts. Clinical improvement was assessed by the visit day on which the symptoms were absent (score 1 on the Likert scale, as described for Outcome 1).
    Time Frame
    Day 0, 3, 7, 14
    Title
    Efficacy - Body temperature normalization
    Description
    Monitor body temperature.
    Time Frame
    Day 0, 3, 7, 14
    Title
    Efficacy - General symptoms of ARVI including influenza
    Description
    Time of disappearance of general symptoms -- ARVI, including influenza. Time of disappearance of general symptoms relating to the respiratory tract, including weakness, headache, myalgia, chills, sore throat, and cough.
    Time Frame
    Day 0, 3, 7, 14
    Title
    Efficacy - Viral antigens
    Description
    Viral antigens evaluated: influenza A and B, respiratory syncytial virus, adenovirus, parainfluenza virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence testing methods. Efficacy assessment: evaluate viral antigen levels at the end of treatment (Day 7) versus the baseline data (Day 0) and compare with the placebo group.
    Time Frame
    Day 0, 3, 7
    Title
    Safety - Adverse events
    Description
    Adverse events occurring during the study were recorded daily by the patients into a patient dairy (Day 0 to Day 14). Clinically relevant laboratory parameters changes outside the normal range were also considered as adverse events. The relationship of the adverse events to the intake of the investigational drug assessed by the investigator.
    Time Frame
    Day 0 to Day 14
    Title
    Safety - Laboratory parameters - Immune status
    Description
    Assessment of the immune status was performed by evaluating the concentration in blood serum of interferon [IFN]-alpha and IFN-gamma, immunoglobulin A, immunoglobulin M, immunoglobulin G. Determination of immunoglobulins А, М, G was performed by turbidimetry. Determination of interferon-alpha and interferon-gamma in human blood serum was carried out using flow cytometer.
    Time Frame
    Day 0, 7, 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ekatarina A. Okhapkina
    Organizational Affiliation
    Smorodintsev Research Institute of Influenza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33558285
    Citation
    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.
    Results Reference
    derived

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

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