NCT Number: NCT04682444
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).
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2 / Phase 3
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Amizon
Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Time frame: Day 0 (baseline), 3, 7, 14.
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.
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.
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, 14.
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.
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.
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.
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.
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.
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.
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.
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.
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: 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.
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: 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 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.
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.
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.
A higher score implies worse clinical outcome.
Time frame: Day 0 (baseline).
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), 3, 7.
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.
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.
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.
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.
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), 7, 14.
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.
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 3, 7, 14.
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.
Joint Stock Company "Farmak"
Industry
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.
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