Acute Respiratory Viral Infections, Human Influenza
Conditions
Keywords
Viral infections, Amizon, Enisamium iodide, Influenza
Brief summary
This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule. Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug. The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system. Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).
Detailed description
Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are able to protect about 80% of otherwise healthy children and adults. However, to develop vaccines against the emerging new pandemic strain of the influenza virus and produce them in the necessary amounts requires at least 6 months. During such interim periods, sufficient protection of the population is essential by effective measures for treatment and prevention of influenza. This randomized, single-blind, clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide) compared with placebo, for the treatment of patients with ARVI, including influenza. Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication. The study design was: randomised, single-blind, 2 parallel groups. Adult patients (18-60 y) with symptoms of ARVI, including influenza took either Amizon tablets (active ingredient enisamium iodide) for 7 days; in the control group patients took placebo tablets for 7 days. Study visits occurred on Day 0 (screening, examination, check inclusion/exclusion criteria, enrollment, randomization, and first intake of study drug); further study visits were on Day 3, Day 7, and Day 14. The effect of treatment was assessed by questioning the patients regarding ARVI and influenza symptoms that included pain, headache, general weakness, sore throat, pain in the joints, fatigue, runny and itchy nose. The severity of symptoms was recorded using a 4-point Likert scale. Further evaluation of the treatment was performed by measuring the vitals signs, laboratory tests that included blood and urine analysis, biochemical analysis, as well as assessing the immune status (including measuring the absolute lymphocytes count, and evaluating the relative concentration of interferon (IFN)-alpha and IFN-gamma, and immunoglobulin (Ig) A, M, and G (IgA, IgM, and IgG).
Interventions
DRUGEnisamium 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).
DRUGPlacebo
Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days.
Sponsors
Joint Stock Company Farmak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Participant, Outcomes Assessor) Matching placebo tablet.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 to 60 years * Patients with ARVI, including influenza, starting not later than for 1 day prior to inclusion in the study: * The body temperature measured axillary above 37.2 °C * Presence of one of the signs of respiratory disease (runny nose, cough, pain / tickling in the throat) * Presence of one of the systemic symptoms (weakness, myalgia, headache , chills, sweating) * Provide written informed consent * Ability to understand the nature of the study and provide written informed consent in accordance with Good Clinical Practice (GCP) and local law
Exclusion criteria
* Age over 60 years and under 18 years old * Presence of allergic reactions * Intolerance to NSAIDs and iodine-containing drugs * Hypersensitivity to the components of the drug * Mental illness that impedes compliance with the research procedure * Pregnancy or breast-feeding * Presence of acute, clinically significant respiratory and cardio vascular insufficiency, functional disorders of liver, kidney, digestive tract (ulcer disease) determined at physical examination or by laboratory screening tests * Presence of congenital defects or serious chronic disease of the lungs, kidneys, cardiovascular system, nervous system, metabolic disorders, psychiatric disorders, confirmed by patients history or during initial examination * The use of preparations of blood cytokine immunoglobulin in for 3 months prior to the study * Chronic use of alcohol and / or drugs * Presence or history of cancer diseases, HIV, hepatitis B and C * Application of immunosuppressive or immunomodulatory drugs for 6-months prior to the study * Women of child-bearing potential and who do not use acceptable measure of contraception or do not plan to use those throughout the study * Any clinical condition that, according to the investigator, will not allow to safely carry out the protocol and take the studied drugs without risk to health * Patients receiving antiviral therapy, * Participation in other clinical trials at the present time or during the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | 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. |
| Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 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. |
| Efficacy: Number of Participants -- Viral Antigens -- Overall | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | 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. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | 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. |
| Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | 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. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | 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. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | 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). |
| Efficacy: Objective Clinical Sum Score | 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. * 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. |
| Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | 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. |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | 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. |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | 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. |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | 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. |
| Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | 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. |
| Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | 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. |
| Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | 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. |
| Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | 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. |
| Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | 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. |
| Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | 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. |
| Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | 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. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 60 |
| 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. | 40 |
| Total | 100 |
Baseline characteristics
| Characteristic | Group 1 - Active Treatment | Group 2 - Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37.0 years | 37.6 years | 37.20 years |
| Body Mass Index | 24.4 kg/m^2 | 25.3 kg/m^2 | 24.7 kg/m^2 |
| Region of Enrollment Russia | 60 participants | 40 participants | 100 participants |
| Sex: Female, Male Female | 38 Participants | 26 Participants | 64 Participants |
| Sex: Female, Male Male | 22 Participants | 14 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 40 |
| other Total, other adverse events | 4 / 60 | 3 / 40 |
| serious Total, serious adverse events | 0 / 60 | 0 / 40 |
Outcome results
Primary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 0: | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 3: | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 7: | 9 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 14: | 44 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 14: | 11 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 0: | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 7: | 4 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Study Day 3: | 0 Participants |
Comparison: Day 7p-value: 0.5547Fisher Exact
Comparison: Day 14p-value: <0.0001Fisher Exact
Primary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 0 days disability | 26 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 1 day disability | 20 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 2 days disability | 12 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | > 2 days disability | 2 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | > 2 days disability | 15 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 0 days disability | 6 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 2 days disability | 9 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | 1 day disability | 10 Participants |
Comparison: Fisher's exact test was used for testing without adjustment for baseline status.p-value: 0.0001Fisher Exact
Primary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 0 Patients who had no detectable viral antigens | 3 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 3 Patients who had no detectable viral antigens | 42 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 7 Patients who had no detectable viral antigens | 59 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 7 Patients who had no detectable viral antigens | 33 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 0 Patients who had no detectable viral antigens | 4 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 3 Patients who had no detectable viral antigens | 10 Participants |
Comparison: Day 3p-value: <0.0001Fisher Exact
Comparison: Day 7p-value: 0.0013Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 3 | 44 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 14 | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 7 | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 7 | 37 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 3 | 23 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Study Day 14 | 39 Participants |
Comparison: Day 3p-value: 0.1253Fisher Exact
Comparison: Day 7p-value: 0.0611Fisher Exact
Comparison: Day 14p-value: 0.4Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 7 | 44 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 14 | 15 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 3 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 14 | 5 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 0 | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 7 | 12 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Study Day 3 | 0 Participants |
Comparison: Day 14p-value: <0.0001Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 3 | 5 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 7 | 35 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 14 | 59 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 14 | 33 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 7 | 19 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Study Day 3 | 1 Participants |
Comparison: Day 3p-value: 0.3973Fisher Exact
Comparison: Day 7p-value: 0.3122Fisher Exact
Comparison: Day 14p-value: 0.0064Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 0: Chills | 55 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 3: Chills | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 7: Chills | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 14: Chills | 60 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 14: Chills | 40 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 0: Chills | 38 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 7: Chills | 40 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Study Day 3: Chills | 40 Participants |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 0: Cough | 1 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 7: Cough | 22 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 3: Cough | 2 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 14: Cough | 57 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 3: Cough | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 0: Cough | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 14: Cough | 19 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Study Day 7: Cough | 3 Participants |
Comparison: Day 3p-value: 0.5152Fisher Exact
Comparison: Day 7p-value: 0.0009Fisher Exact
Comparison: Day 14p-value: <0.0001Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 0: Patients without perceived elevated body temperature | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 3: Patients without perceived elevated body temperature | 44 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 7: Patients without perceived elevated body temperature | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 14: Patients without perceived elevated body temperature | 60 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 14: Patients without perceived elevated body temperature | 39 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 0: Patients without perceived elevated body temperature | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 7: Patients without perceived elevated body temperature | 37 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Study Day 3: Patients without perceived elevated body temperature | 23 Participants |
Comparison: Day 3p-value: 0.1253Fisher Exact
Comparison: Day 7p-value: 0.0611Fisher Exact
Comparison: Day 14p-value: 0.4Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 0: Headache | 4 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 7: Headache | 54 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 3: Headache | 29 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 14: Headache | 60 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 14: Headache | 37 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 0: Headache | 6 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 3: Headache | 15 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Study Day 7: Headache | 27 Participants |
Comparison: Day 3p-value: 0.3107Fisher Exact
Comparison: Day 7p-value: 0.0083Fisher Exact
Comparison: Day 14p-value: 0.0611Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 7: Myalgia | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 0: Myalgia | 28 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 14: Myalgia | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 3: Myalgia | 59 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 14: Myalgia | 40 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 0: Myalgia | 26 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 7: Myalgia | 40 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Study Day 3: Myalgia | 37 Participants |
Comparison: Day 3p-value: 0.2988Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 7: Sore throat | 39 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 3: Sore throat | 15 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 14: Sore throat | 59 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 0: Sore throat | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 14: Sore throat | 35 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 3: Sore throat | 7 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 7: Sore throat | 19 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Study Day 0: Sore throat | 0 Participants |
Comparison: Day 3p-value: 0.4636Fisher Exact
Comparison: Day 7p-value: 0.1Fisher Exact
Comparison: Day 14p-value: 0.0363Fisher Exact
Secondary
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.
Population: Intention to treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 0: | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 3: | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 7: | 9 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 14: | 57 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 14: | 18 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 0: | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 7: | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Study Day 3: | 0 Participants |
Comparison: Day 7p-value: 0.0474Fisher Exact
Comparison: Day 14p-value: <0.0001Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 0: Weakness | 1 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 3: Weakness | 18 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 7: Weakness | 41 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 14: Weakness | 58 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 14: Weakness | 33 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 0: Weakness | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 7: Weakness | 18 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Study Day 3: Weakness | 1 Participants |
Comparison: Day 3p-value: 0.0005Fisher Exact
Comparison: Day 7p-value: 0.0238Fisher Exact
Comparison: Day 14p-value: 0.0277Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | >38.1 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | >38.1 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 37.1-37.5 | 33 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 37.6-38.0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 37.1-37.5 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 37.6-38.0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 36.6-37-0 | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 37.6-38.0 | 26 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | >38.1 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 37.1-37.5 | 16 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 37.6-38.0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 36.6-37-0 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 37.1-37.5 | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 36.6-37-0 | 44 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 36.6-37-0 | 60 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | >38.1 | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 36.6-37-0 | 39 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | >38.1 | 3 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 36.6-37-0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 37.6-38.0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 37.6-38.0 | 12 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 0 | 37.1-37.5 | 25 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | >38.1 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 37.6-38.0 | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 37.1-37.5 | 16 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 3 | 36.6-37-0 | 23 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | >38.1 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 37.1-37.5 | 3 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 7 | 36.6-37-0 | 37 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | >38.1 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 37.6-38.0 | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Study Day 14 | 37.1-37.5 | 1 Participants |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 3 Patients who had no detectable viral antigen | 5 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 7 Patients who had no detectable viral antigen | 8 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 3 Patients who had no detectable viral antigen | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Day 7 Patients who had no detectable viral antigen | 5 Participants |
Comparison: Day 3p-value: 0.0406Fisher Exact
Comparison: Day 7p-value: 0.2Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 3 Patients who had no detectable viral antigen | 20 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 7 Patients who had no detectable viral antigen | 25 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 3 Patients who had no detectable viral antigen | 3 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 7 Patients who had no detectable viral antigen | 16 Participants |
Comparison: Day 3p-value: 0.0002Fisher Exact
Comparison: Day 7p-value: 0.4048Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 0 Patients who had no detectable viral antigens | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 3 Patients who had no detectable viral antigens | 25 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 7 Patients who had no detectable viral antigens | 32 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 0 Patients who had no detectable viral antigens | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 3 Patients who had no detectable viral antigens | 5 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Day 7 Patients who had no detectable viral antigens | 20 Participants |
Comparison: Day 3p-value: 0.0002Fisher Exact
Comparison: Day 7p-value: 0.1614Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 3 Patients who had no detectable viral antigen | 5 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 7 Patients who had no detectable viral antigen | 7 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 0 Patients who had no detectable viral antigen | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 3 Patients who had no detectable viral antigen | 2 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Day 7 Patients who had no detectable viral antigen | 4 Participants |
Comparison: Day 3p-value: 0.5581Fisher Exact
Comparison: Day 7p-value: 0.4167Fisher Exact
Secondary
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).
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | influenza A (H1N1) | 12 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza A and Adenovirus (Combination of antigens) | 10 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza B | 7 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza A (H3N2) | 14 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Respiratory syncytial virus (Mono) | 2 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Adenovirus (Mono) | 8 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Non-differentiated acute respiratory viral infection (ARVI) | 3 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Parainfluenza (Mono) | 4 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Non-differentiated acute respiratory viral infection (ARVI) | 4 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | influenza A (H1N1) | 9 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza A (H3N2) | 8 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza B | 5 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Adenovirus (Mono) | 8 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Influenza A and Adenovirus (Combination of antigens) | 4 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Parainfluenza (Mono) | 1 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Respiratory syncytial virus (Mono) | 1 Participants |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 0 Patients who had no detectable viral antigens | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 3 Patients who had no detectable viral antigens | 5 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 7 Patients who had no detectable viral antigens | 10 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 7 Patients who had no detectable viral antigens | 2 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 0 Patients who had no detectable viral antigens | 0 Participants |
| Group 2 - Placebo | Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Day 3 Patients who had no detectable viral antigens | 0 Participants |
Comparison: Day 3p-value: 0.2208Fisher Exact
Comparison: Day 7p-value: 0.0659Fisher Exact
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Objective Clinical Sum Score | Study Day 0: | 9.53 score | Standard Error 0.09 |
| Group 1 - Active Treatment - Amizon | Efficacy: Objective Clinical Sum Score | Study Day 3: | 7.37 score | Standard Error 0.09 |
| Group 1 - Active Treatment - Amizon | Efficacy: Objective Clinical Sum Score | Study Day 7: | 6.02 score | Standard Error 0.13 |
| Group 1 - Active Treatment - Amizon | Efficacy: Objective Clinical Sum Score | Study Day 14: | 4.55 score | Standard Error 0.12 |
| Group 2 - Placebo | Efficacy: Objective Clinical Sum Score | Study Day 14: | 5.60 score | Standard Error 0.17 |
| Group 2 - Placebo | Efficacy: Objective Clinical Sum Score | Study Day 0: | 9.65 score | Standard Error 0.17 |
| Group 2 - Placebo | Efficacy: Objective Clinical Sum Score | Study Day 7: | 6.48 score | Standard Error 0.16 |
| Group 2 - Placebo | Efficacy: Objective Clinical Sum Score | Study Day 3: | 7.83 score | Standard Error 0.15 |
Comparison: Day 3p-value: 0.012Wilcoxon (Mann-Whitney)
Comparison: Day 7p-value: 0.036Wilcoxon (Mann-Whitney)
Comparison: Day 14p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Severe | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Mild | 24 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Absent | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Mild | 8 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Moderate | 51 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Severe | 1 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Absent | 5 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Mild | 44 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Moderate | 11 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Severe | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Moderate | 1 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Severe | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Absent | 59 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Mild | 1 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Moderate | 0 Participants |
| Group 1 - Active Treatment - Amizon | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Absent | 35 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Severe | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Absent | 19 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Moderate | 14 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Severe | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Mild | 7 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Absent | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Severe | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Mild | 4 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Mild | 19 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Moderate | 36 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Absent | 33 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 0 | Severe | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 7 | Moderate | 2 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Absent | 1 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 14 | Moderate | 0 Participants |
| Group 2 - Placebo | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Study Day 3 | Mild | 25 Participants |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 0: | 15.7 score on a 4-point Likert scale |
| Group 1 - Active Treatment - Amizon | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 3: | 11 score on a 4-point Likert scale |
| Group 1 - Active Treatment - Amizon | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 7: | 8.4 score on a 4-point Likert scale |
| Group 1 - Active Treatment - Amizon | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 14: | 7.1 score on a 4-point Likert scale |
| Group 2 - Placebo | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 14: | 8.0 score on a 4-point Likert scale |
| Group 2 - Placebo | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 0: | 15.4 score on a 4-point Likert scale |
| Group 2 - Placebo | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 7: | 9.6 score on a 4-point Likert scale |
| Group 2 - Placebo | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Study Day 3: | 11.9 score on a 4-point Likert scale |
Comparison: Day 3p-value: 0.0065MMRM
Comparison: Day 7p-value: <0.0001MMRM
Comparison: Day 14p-value: <0.0001MMRM
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Worsened | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Worsened | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Complete recovery | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Significant improve | 39 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Moderate improve | 21 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | No significant change | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Complete recovery | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Significant improve | 36 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Moderate improve | 24 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | No significant change | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Worsened | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Complete recovery | 12 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Significant improve | 40 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Moderate improve | 7 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | No significant change | 1 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Worsened | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Complete recovery | 11 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Significant improve | 42 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Moderate improve | 6 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | No significant change | 1 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Complete recovery | 56 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Significant improve | 4 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Moderate improve | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | No significant change | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Worsened | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Complete recovery | 56 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Significant improve | 4 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Moderate improve | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | No significant change | 0 Participants |
| Group 1 - Active Treatment - Amizon | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Moderate improve | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Significant improve | 27 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Significant improve | 21 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Complete recovery | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Complete recovery | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Complete recovery | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Significant improve | 9 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | No significant change | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Moderate improve | 28 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | No significant change | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | No significant change | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Investigator | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Moderate improve | 10 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Significant improve | 6 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | No significant change | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Moderate improve | 31 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Patient | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | No significant change | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Moderate improve | 3 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 3: Patient | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Complete recovery | 13 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Complete recovery | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Complete recovery | 13 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Significant improve | 30 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Investigator | Significant improve | 21 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | Moderate improve | 8 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 14: Patient | Worsened | 0 Participants |
| Group 2 - Placebo | Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Day 7: Investigator | No significant change | 2 Participants |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgA | 2.209 grams/liter | Standard Error 0.129 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgM | 1.442 grams/liter | Standard Error 0.093 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgG | 12.175 grams/liter | Standard Error 0.397 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgA | 2.157 grams/liter | Standard Error 0.117 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgA | 2.238 grams/liter | Standard Error 0.131 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgM | 1.552 grams/liter | Standard Error 0.113 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgG | 12.247 grams/liter | Standard Error 0.384 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgG | 12.388 grams/liter | Standard Error 0.395 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgM | 1.525 grams/liter | Standard Error 0.112 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgG | 11.753 grams/liter | Standard Error 0.39 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgA | 2.296 grams/liter | Standard Error 0.136 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgA | 2.273 grams/liter | Standard Error 0.14 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgM | 1.338 grams/liter | Standard Error 0.104 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 0, IgG | 11.383 grams/liter | Standard Error 0.336 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgM | 1.315 grams/liter | Standard Error 0.104 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgG | 11.423 grams/liter | Standard Error 0.345 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 14, IgM | 1.400 grams/liter | Standard Error 0.109 |
| Group 2 - Placebo | Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Day 7, IgA | 2.303 grams/liter | Standard Error 0.136 |
Secondary
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.
Population: Intention-to-treat. All randomized patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Active Treatment - Amizon | 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 |
| Group 1 - Active Treatment - Amizon | 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 |
| Group 1 - Active Treatment - Amizon | 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 |
| Group 1 - Active Treatment - Amizon | 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 |
| Group 1 - Active Treatment - Amizon | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 14, IFN-gamma | 41.313 picograms/mL | Standard Error 0.77 |
| Group 1 - Active Treatment - Amizon | 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 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 14, IFN-gamma | 30.393 picograms/mL | Standard Error 0.892 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 0, IFN-gamma | 33.008 picograms/mL | Standard Error 1.28 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 7, IFN-alpha | 31.768 picograms/mL | Standard Error 1.345 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 7, IFN-gamma | 30.478 picograms/mL | Standard Error 0.694 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 14, IFN-alpha | 29.388 picograms/mL | Standard Error 1.592 |
| Group 2 - Placebo | Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Day 0, IFN-alpha | 22.541 picograms/mL | Standard Error 1.676 |
Comparison: Day 0, IFN-alphap-value: 0.941Fisher Exact
Comparison: Day 0, IFN-gammap-value: 0.943Fisher Exact
Comparison: Day 7, IFN-alphap-value: <0.001Fisher Exact
Comparison: Day 7, IFN-gammap-value: <0.001Fisher Exact
Comparison: Day 14, IFN-alphap-value: 0.625Fisher Exact
Comparison: Day 14, IFN-gammap-value: <0.001Fisher Exact