Trial Outcomes & Findings for Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza. (NCT NCT04682444)
NCT ID: NCT04682444
Last Updated: 2026-01-08
Results Overview
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.
COMPLETED
PHASE2/PHASE3
100 participants
Day 0 (baseline), 3, 7, 14.
2026-01-08
Participant Flow
Participant milestones
| Measure |
Group 1 - Active Treatment
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
40
|
|
Overall Study
COMPLETED
|
60
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
Baseline characteristics by cohort
| Measure |
Group 1 - Active Treatment
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
n=18 Participants
|
37.6 years
n=17 Participants
|
37.20 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=18 Participants
|
26 Participants
n=17 Participants
|
64 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=18 Participants
|
14 Participants
n=17 Participants
|
36 Participants
n=35 Participants
|
|
Region of Enrollment
Russia
|
60 participants
n=18 Participants
|
40 participants
n=17 Participants
|
100 participants
n=35 Participants
|
|
Body Mass Index
|
24.4 kg/m^2
n=18 Participants
|
25.3 kg/m^2
n=17 Participants
|
24.7 kg/m^2
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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
Study Day 3:
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall
Study Day 0:
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall
Study Day 7:
|
9 Participants
|
4 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall
Study Day 14:
|
44 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Days Without Routine Activities -- Summary
2 days disability
|
12 Participants
|
9 Participants
|
|
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary
> 2 days disability
|
2 Participants
|
15 Participants
|
|
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary
0 days disability
|
26 Participants
|
6 Participants
|
|
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary
1 day disability
|
20 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigens -- Overall
Day 0 Patients who had no detectable viral antigens
|
3 Participants
|
4 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Overall
Day 3 Patients who had no detectable viral antigens
|
42 Participants
|
10 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Overall
Day 7 Patients who had no detectable viral antigens
|
59 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention to treat
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).
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptoms -- Overall
Study Day 0:
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall
Study Day 3:
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall
Study Day 7:
|
9 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall
Study Day 14:
|
57 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)
Study Day 0:
|
15.7 score on a 4-point Likert scale
Interval 11.0 to 19.0
|
15.4 score on a 4-point Likert scale
Interval 11.0 to 18.0
|
|
Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)
Study Day 3:
|
11 score on a 4-point Likert scale
Interval 8.0 to 15.0
|
11.9 score on a 4-point Likert scale
Interval 9.0 to 17.0
|
|
Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)
Study Day 7:
|
8.4 score on a 4-point Likert scale
Interval 7.0 to 12.0
|
9.6 score on a 4-point Likert scale
Interval 7.0 to 14.0
|
|
Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)
Study Day 14:
|
7.1 score on a 4-point Likert scale
Interval 7.0 to 10.0
|
8.0 score on a 4-point Likert scale
Interval 7.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Chills
Study Day 0: Chills
|
55 Participants
|
38 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills
Study Day 3: Chills
|
60 Participants
|
40 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills
Study Day 7: Chills
|
60 Participants
|
40 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills
Study Day 14: Chills
|
60 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Cough
Study Day 0: Cough
|
1 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough
Study Day 3: Cough
|
2 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough
Study Day 7: Cough
|
22 Participants
|
3 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough
Study Day 14: Cough
|
57 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Elevated Body Temperature
Study Day 0: Patients without perceived elevated body temperature
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature
Study Day 3: Patients without perceived elevated body temperature
|
44 Participants
|
23 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature
Study Day 7: Patients without perceived elevated body temperature
|
60 Participants
|
37 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature
Study Day 14: Patients without perceived elevated body temperature
|
60 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Sore Throat
Study Day 0: Sore throat
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat
Study Day 3: Sore throat
|
15 Participants
|
7 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat
Study Day 7: Sore throat
|
39 Participants
|
19 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat
Study Day 14: Sore throat
|
59 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Headache
Study Day 0: Headache
|
4 Participants
|
6 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache
Study Day 3: Headache
|
29 Participants
|
15 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache
Study Day 7: Headache
|
54 Participants
|
27 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache
Study Day 14: Headache
|
60 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Myalgia
Study Day 0: Myalgia
|
28 Participants
|
26 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia
Study Day 3: Myalgia
|
59 Participants
|
37 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia
Study Day 7: Myalgia
|
60 Participants
|
40 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia
Study Day 14: Myalgia
|
60 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Subjective Symptom -- Weakness
Study Day 3: Weakness
|
18 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness
Study Day 0: Weakness
|
1 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness
Study Day 7: Weakness
|
41 Participants
|
18 Participants
|
|
Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness
Study Day 14: Weakness
|
58 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Symptom -- Body Temperature
Study Day 14
|
60 Participants
|
39 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature
Study Day 0
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature
Study Day 3
|
44 Participants
|
23 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature
Study Day 7
|
60 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 0 · >38.1
|
1 Participants
|
3 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 0 · 37.6-38.0
|
26 Participants
|
12 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 0 · 37.1-37.5
|
33 Participants
|
25 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 0 · 36.6-37-0
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 3 · >38.1
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 3 · 37.6-38.0
|
0 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 3 · 37.1-37.5
|
16 Participants
|
16 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 3 · 36.6-37-0
|
44 Participants
|
23 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 7 · >38.1
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 7 · 37.6-38.0
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 7 · 37.1-37.5
|
0 Participants
|
3 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 7 · 36.6-37-0
|
60 Participants
|
37 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 14 · >38.1
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 14 · 37.6-38.0
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 14 · 37.1-37.5
|
0 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges
Study Day 14 · 36.6-37-0
|
60 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Symptom -- Lungs Auscultation
Study Day 0
|
0 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation
Study Day 3
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation
Study Day 7
|
44 Participants
|
12 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation
Study Day 14
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 Symptom -- Pharyngeal Hyperemia
Study Day 0
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia
Study Day 3
|
5 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia
Study Day 7
|
35 Participants
|
19 Participants
|
|
Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia
Study Day 14
|
59 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 0 · Mild
|
8 Participants
|
4 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 7 · Mild
|
24 Participants
|
19 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 3 · Mild
|
44 Participants
|
25 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 14 · Absent
|
59 Participants
|
33 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 0 · Absent
|
0 Participants
|
0 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 0 · Moderate
|
51 Participants
|
36 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 0 · Severe
|
1 Participants
|
0 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 3 · Absent
|
5 Participants
|
1 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 3 · Moderate
|
11 Participants
|
14 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 3 · Severe
|
0 Participants
|
0 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 7 · Absent
|
35 Participants
|
19 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 7 · Moderate
|
1 Participants
|
2 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 7 · Severe
|
0 Participants
|
0 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 14 · Mild
|
1 Participants
|
7 Participants
|
|
Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity
Study Day 14 · Moderate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Efficacy: Objective Clinical Sum Score
Study Day 0:
|
9.53 score
Standard Error 0.09
|
9.65 score
Standard Error 0.17
|
|
Efficacy: Objective Clinical Sum Score
Study Day 3:
|
7.37 score
Standard Error 0.09
|
7.83 score
Standard Error 0.15
|
|
Efficacy: Objective Clinical Sum Score
Study Day 7:
|
6.02 score
Standard Error 0.13
|
6.48 score
Standard Error 0.16
|
|
Efficacy: Objective Clinical Sum Score
Study Day 14:
|
4.55 score
Standard Error 0.12
|
5.60 score
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Day 0 (baseline).Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigens -- Baseline Status
Adenovirus (Mono)
|
8 Participants
|
8 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Parainfluenza (Mono)
|
4 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
influenza A (H1N1)
|
12 Participants
|
9 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Influenza A (H3N2)
|
14 Participants
|
8 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Influenza B
|
7 Participants
|
5 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Influenza A and Adenovirus (Combination of antigens)
|
10 Participants
|
4 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Respiratory syncytial virus (Mono)
|
2 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Viral Antigens -- Baseline Status
Non-differentiated acute respiratory viral infection (ARVI)
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=26 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=17 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigen -- Influenza Type A
Day 0 Patients who had no detectable viral antigen
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A
Day 3 Patients who had no detectable viral antigen
|
20 Participants
|
3 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A
Day 7 Patients who had no detectable viral antigen
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=33 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=22 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigen -- Influenza Type A or Type B
Day 0 Patients who had no detectable viral antigens
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B
Day 3 Patients who had no detectable viral antigens
|
25 Participants
|
5 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B
Day 7 Patients who had no detectable viral antigens
|
32 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=7 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=5 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigen -- Influenza Type B
Day 0 Patients who had no detectable viral antigen
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B
Day 3 Patients who had no detectable viral antigen
|
5 Participants
|
2 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B
Day 7 Patients who had no detectable viral antigen
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=8 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=8 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigen -- Adenovirus
Day 0 Patients who had no detectable viral antigen
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Adenovirus
Day 3 Patients who had no detectable viral antigen
|
5 Participants
|
1 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Adenovirus
Day 7 Patients who had no detectable viral antigen
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 3, 7.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=10 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=4 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: 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 -- Viral Antigen -- Viral Antigen Combination
Day 0 Patients who had no detectable viral antigens
|
0 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination
Day 3 Patients who had no detectable viral antigens
|
5 Participants
|
0 Participants
|
|
Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination
Day 7 Patients who had no detectable viral antigens
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 0, IgG
|
12.247 grams/liter
Standard Error 0.384
|
11.383 grams/liter
Standard Error 0.336
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 7, IgA
|
2.209 grams/liter
Standard Error 0.129
|
2.303 grams/liter
Standard Error 0.136
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 7, IgM
|
1.525 grams/liter
Standard Error 0.112
|
1.315 grams/liter
Standard Error 0.104
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 7, IgG
|
12.175 grams/liter
Standard Error 0.397
|
11.423 grams/liter
Standard Error 0.345
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 14, IgA
|
2.238 grams/liter
Standard Error 0.131
|
2.296 grams/liter
Standard Error 0.136
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 14, IgM
|
1.552 grams/liter
Standard Error 0.113
|
1.400 grams/liter
Standard Error 0.109
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 14, IgG
|
12.388 grams/liter
Standard Error 0.395
|
11.753 grams/liter
Standard Error 0.390
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 0, IgM
|
1.442 grams/liter
Standard Error 0.093
|
1.338 grams/liter
Standard Error 0.104
|
|
Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G
Day 0, IgA
|
2.157 grams/liter
Standard Error 0.117
|
2.273 grams/liter
Standard Error 0.140
|
SECONDARY outcome
Timeframe: Day 0 (baseline), 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 0, IFN-alpha
|
22.290 picograms/mL
Standard Error 1.264
|
22.541 picograms/mL
Standard Error 1.676
|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 7, IFN-gamma
|
44.670 picograms/mL
Standard Error 0.765
|
30.478 picograms/mL
Standard Error 0.694
|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 14, IFN-alpha
|
30.072 picograms/mL
Standard Error 1.123
|
29.388 picograms/mL
Standard Error 1.592
|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 0, IFN-gamma
|
33.168 picograms/mL
Standard Error 0.912
|
33.008 picograms/mL
Standard Error 1.280
|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 7, IFN-alpha
|
37.563 picograms/mL
Standard Error 1.308
|
31.768 picograms/mL
Standard Error 1.345
|
|
Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)
Day 14, IFN-gamma
|
41.313 picograms/mL
Standard Error 0.770
|
30.393 picograms/mL
Standard Error 0.892
|
SECONDARY outcome
Timeframe: Day 3, 7, 14.Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Group 1 - Active Treatment - Amizon
n=60 Participants
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 250 mg of enisamium iodide.
Enisamium Iodide: 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).
|
Group 2 - Placebo
n=40 Participants
Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Investigator · Moderate improve
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Patient · Worsened
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Investigator · Moderate improve
|
7 Participants
|
8 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Investigator · Complete recovery
|
12 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Investigator · Worsened
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Patient · Moderate improve
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Patient · No significant change
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Investigator · Complete recovery
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Investigator · Significant improve
|
39 Participants
|
9 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Investigator · Moderate improve
|
21 Participants
|
28 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Investigator · No significant change
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Investigator · Worsened
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Patient · Complete recovery
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Patient · Significant improve
|
36 Participants
|
6 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Patient · Moderate improve
|
24 Participants
|
31 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 3: Patient · No significant change
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Investigator · Significant improve
|
40 Participants
|
30 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Investigator · No significant change
|
1 Participants
|
2 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Patient · Complete recovery
|
11 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Patient · Significant improve
|
42 Participants
|
27 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Patient · Moderate improve
|
6 Participants
|
10 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Patient · No significant change
|
1 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 7: Patient · Worsened
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Investigator · Complete recovery
|
56 Participants
|
13 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Investigator · Significant improve
|
4 Participants
|
21 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Investigator · No significant change
|
0 Participants
|
3 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Investigator · Worsened
|
0 Participants
|
0 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Patient · Complete recovery
|
56 Participants
|
13 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Patient · Significant improve
|
4 Participants
|
21 Participants
|
|
Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)
Day 14: Patient · Worsened
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 - Active Treatment
Group 2 - Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 - Active Treatment
n=60 participants at risk
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.
Enisamium Iodide: Patients ingested Amizon tablets without chewing, after meal, 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).
|
Group 2 - Placebo
n=40 participants at risk
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.
Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 0.5 g (2 tablets), 3 times a day, for 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Bitter taste in mouth
|
3.3%
2/60 • Number of events 2 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
2.5%
1/40 • Number of events 1 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Gastrointestinal disorders
Heartburn
|
1.7%
1/60 • Number of events 1 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
0.00%
0/40 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Gastrointestinal disorders
Burning sensation
|
1.7%
1/60 • Number of events 1 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
0.00%
0/40 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory disease
|
0.00%
0/60 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
2.5%
1/40 • Number of events 1 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
2.5%
1/40 • Number of events 1 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Skin and subcutaneous tissue disorders
Allergic rash
|
0.00%
0/60 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
5.0%
2/40 • Number of events 2 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/60 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
5.0%
2/40 • Number of events 2 • From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place