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).
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 immunoglobulin (Ig) A, M, and G (IgA, IgM, and IgG).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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).
Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 (baseline), 3, 7.
Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall
Count of participants WITHOUT overall subjective symptoms. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. Evaluate the number of participants in the treatment and the placebo groups without the subjective symptoms from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. The subjective symptoms were assessed using a 4-point Likert scale, ranging from score 1 (absent symptoms ) to score 4 (severe symptoms).
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)
Subjective symptom sum score. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. The subjective symptoms were assessed using a 4-point Likert scale for the individual assessment of the severity of the above 7 symptoms, ranging from absent (0), mild (1), moderate (2), or severe (3). A higher score implies worse outcome.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills
Chills. Count of participants WITHOUT the subjective symptom: chills. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough
Cough. Count of participants WITHOUT the subjective symptom: cough. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature
Count of participants WITHOUT perceived elevated body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat
Subjective symptoms. Count of participants WITHOUT the subjective symptom: sore throat. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache
Subjective symptoms. Count of participants WITHOUT the subjective symptom: headache. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia
Myalgia. Count of participants WITHOUT the subjective symptom: myalgia. Evaluate the number of participants in the active treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness
Subjective symptoms. Count of participants WITHOUT the subjective symptom: weakness. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature
Efficacy: Count of participants WITHOUT objective symptom: Body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Body temperature. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, with respect to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation
Efficacy: Count of participants WITHOUT objective symptom: Lungs auscultation (abnormal breath sounds, detected using a stethoscope). Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia
Efficacy: Number of participants WITHOUT objective Symptom: Pharyngeal Hyperemia. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Pharyngeal hyperemia. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Severity was assessed by the investigator, using a 4-point score scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Objective Clinical Sum Score
Objective clinical sum score. Objective symptoms of acute respiratory viral infection (ARVI), were monitored. For the objective clinical sum score, clinical status was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. A score system (score points) that was used to assess participants' health, was based on objective symptoms scores, shown below. * Blood pressure: normal=0 points; abnormal=4 points. * Lung auscultation: vesicular breath sound=0 points; wheezing=2 points; crepitation=4 points. * Heart sound; clear heart sounds=0 points; rhythmic heart sounds=0 points; noisy heart sounds=2 points; arrhythmic heart sounds=2 points. A higher score implies worse clinical outcome.
Time frame: Day 0 (baseline), 3, 7, 14.
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Count of randomised participants and their viral antigen types at baseline. Viral antigens evaluated: adenovirus, corona virus, influenza A (and subtypes), influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods.
Time frame: Day 0 (baseline).
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A
Count of participants who did NOT have a detectable viral antigen -- influenza Type A Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was 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.
Time frame: Day 0 (baseline), 3, 7.
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B
Viral antigen: Count of participants who did NOT have detectable viral antigen -- influenza Type A or Type B. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was 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.
Time frame: Day 0 (baseline), 3, 7.
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B
Viral antigen: Number of participants who did NOT have detectable viral antigen -- influenza Type B. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was 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.
Time frame: Day 0 (baseline), 3, 7.
Efficacy: Number of Participants -- Viral Antigen -- Adenovirus
Viral antigen: Count of participants who did NOT have detectable viral antigen -- Adenovirus. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was 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.
Time frame: Day 0 (baseline), 3, 7.
Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination
Viral antigen: Count of participants who did NOT have detectable viral antigen -- viral antigen combination. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was 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.
Time frame: Day 0 (baseline), 3, 7.
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Assessment of the immune status was performed by evaluating the concentration in blood serum of immunoglobulin A (IgA), immunoglobulin M (IgM), immunoglobulin G (IgG). Determination of IgA, IgM, and IgG was performed by turbidimetry.
Time frame: Day 0 (baseline), 7, 14.
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Assessment of the immune status was performed by evaluating the concentration in blood serum of IFN-alpha and IFN-gamma. Determination of interferon alpha (INF-alpha) and interferon gamma (INF-gamma) in human blood serum was carried out using flow cytometer.
Time frame: Day 0 (baseline), 7, 14.
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Overall treatment efficacy. Evaluate the overall efficacy of the treatment by the investigator and by the participants. Results show the number of participants for each assessed category of the health status.
Time frame: Day 3, 7, 14.
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