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This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule.
Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug.
The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system.
Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).
Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are able to protect about 80% of otherwise healthy children and adults. However, to develop vaccines against the emerging new pandemic strain of the influenza virus and produce them in the necessary amounts requires at least 6 months. During such interim periods, sufficient protection of the population is essential by effective measures for treatment and prevention of influenza.
This randomized, single-blind, clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide) compared with placebo, for the treatment of patients with ARVI, including influenza.
Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication.
The study design was: randomised, single-blind, 2 parallel groups. Adult patients (18-60 y) with symptoms of ARVI, including influenza took either Amizon tablets (active ingredient enisamium iodide) for 7 days; in the control group patients took placebo tablets for 7 days. Study visits occurred on Day 0 (screening, examination, check inclusion/exclusion criteria, enrollment, randomization, and first intake of study drug); further study visits were on Day 3, Day 7, and Day 14.
The effect of treatment was assessed by questioning the patients regarding ARVI and influenza symptoms that included pain, headache, general weakness, sore throat, pain in the joints, fatigue, runny and itchy nose. The severity of symptoms was recorded using a 4-point Likert scale.
Further evaluation of the treatment was performed by measuring the vitals signs, laboratory tests that included blood and urine analysis, biochemical analysis, as well as assessing the immune status (including measuring the absolute lymphocytes count, and evaluating the relative concentration of interferon (IFN)-alpha and IFN-gamma, and immunoglobulin (Ig) A, M, and G (IgA, IgM, and IgG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Active Treatment - Amizon | Experimental | Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (as 2 tablets, each tablet containing 250 mg enisamium iodide) after a meal, 3 times a day, for 7 days. |
|
| Group 2 - Placebo | Placebo Comparator | Patient who were randomized into Group 2 ingested placebo tablets 500 mg (2 tablets), after a meal 3 times a day, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enisamium Iodide | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | Count of participants who had days WITHOUT routine activities. Disability to perform routine tasks and activities were reported by the participants to the investigator at each study visit. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Viral Antigens -- Overall | Viral antigens that were evaluated: adenovirus, corona virus, influenza A, influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was based on the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. Results represent the count of participants who did NOT have detectable viral antigens. | Day 0 (baseline), 3, 7. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekatarina A. Okhapkina | Smorodintsev Research Institute of Influenza | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33558285 | Derived | Te Velthuis AJW, Zubkova TG, Shaw M, Mehle A, Boltz D, Gmeinwieser N, Stammer H, Milde J, Muller L, Margitich V. Enisamium Reduces Influenza Virus Shedding and Improves Patient Recovery by Inhibiting Viral RNA Polymerase Activity. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02605-20. doi: 10.1128/AAC.02605-20. Print 2021 Mar 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients with ARVI, including influenza, with disease onset no later than 1 day prior to inclusion to the study. The diagnosis was based on axillary body temperature ≥ 37.2°C, the presence of at least one symptom of respiratory tract infection (rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis, cough), and one general infection symptom (weakness, malaise, myalgia, headache, fever, decreased appetite). The diagnosis was confirmed by viral antigen immunofluorescence testing of nasal swabs.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
|
From the study start (Day 0), throughout the study treatment (7 days), and up to the follow-up study visit (Day 14).
Adverse event (AE) was defined as any effect (unfavourable from medical viewpoint) that was experienced by a study subject exposed to the investigational drug, irrespective of its relatedness to study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Active Treatment | Patient who were randomized into Group 1 ingested Amizon tablets 0.5 g (2 tablets) after a meal, 3 times a day, for 7 days; each tablet contains 0.25 g of enisamium iodide. Enisamium Iodide: Patients ingested Amizon tablets without chewing, after meal, as follows: 2 tablets (total dose 0.5 g) 3 times a day, for 7 days. Each tablet contains 0.25 g of Nmethyl-4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bitter taste in mouth | Gastrointestinal disorders | MedDRA 99.9 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Enquiry Manager | Farmak | + 38 (067) 464-28-27 | Farmak-Clinical-Affairs@regenold.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C079927 | enisamium iodide |
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Double (Participant, Outcomes Assessor) Matching placebo tablet.
|
| Placebo | Drug | Patients ingested placebo tablets without chewing, after meal, in the dose 500 mg (2 tablets), 3 times a day, for 7 days. |
|
| Day 0 (baseline), 3, 7, 14. |
| Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Subjective symptom sum score. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. The subjective symptoms were assessed using a 4-point Likert scale for the individual assessment of the severity of the above 7 symptoms, ranging from absent (0), mild (1), moderate (2), or severe (3). A higher score implies worse outcome. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Chills. Count of participants WITHOUT the subjective symptom: chills. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Cough. Count of participants WITHOUT the subjective symptom: cough. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Count of participants WITHOUT perceived elevated body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Subjective symptoms. Count of participants WITHOUT the subjective symptom: sore throat. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Subjective symptoms. Count of participants WITHOUT the subjective symptom: headache. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Myalgia. Count of participants WITHOUT the subjective symptom: myalgia. Evaluate the number of participants in the active treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Subjective symptoms. Count of participants WITHOUT the subjective symptom: weakness. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Efficacy: Count of participants WITHOUT objective symptom: Body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Body temperature. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, with respect to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Efficacy: Count of participants WITHOUT objective symptom: Lungs auscultation (abnormal breath sounds, detected using a stethoscope). Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Efficacy: Number of participants WITHOUT objective Symptom: Pharyngeal Hyperemia. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. | Day 0 (baseline), 3, 7, 14. |
| Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Pharyngeal hyperemia. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Severity was assessed by the investigator, using a 4-point score scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Objective Clinical Sum Score | Objective clinical sum score. Objective symptoms of acute respiratory viral infection (ARVI), were monitored. For the objective clinical sum score, clinical status was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. A score system (score points) that was used to assess participants' health, was based on objective symptoms scores, shown below.
A higher score implies worse clinical outcome. | Day 0 (baseline), 3, 7, 14. |
| Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Count of randomised participants and their viral antigen types at baseline. Viral antigens evaluated: adenovirus, corona virus, influenza A (and subtypes), influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. | Day 0 (baseline). |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Count of participants who did NOT have a detectable viral antigen -- influenza Type A Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. | Day 0 (baseline), 3, 7. |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B | Viral antigen: Count of participants who did NOT have detectable viral antigen -- influenza Type A or Type B. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. | Day 0 (baseline), 3, 7. |
| Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B | Viral antigen: Number of participants who did NOT have detectable viral antigen -- influenza Type B. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. | Day 0 (baseline), 3, 7. |
| Efficacy: Number of Participants -- Viral Antigen -- Adenovirus | Viral antigen: Count of participants who did NOT have detectable viral antigen -- Adenovirus. Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. | Day 0 (baseline), 3, 7. |
| Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination | Viral antigen: Count of participants who did NOT have detectable viral antigen -- viral antigen combination. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. | Day 0 (baseline), 3, 7. |
| Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G | Assessment of the immune status was performed by evaluating the concentration in blood serum of immunoglobulin A (IgA), immunoglobulin M (IgM), immunoglobulin G (IgG). Determination of IgA, IgM, and IgG was performed by turbidimetry. | Day 0 (baseline), 7, 14. |
| Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma) | Assessment of the immune status was performed by evaluating the concentration in blood serum of IFN-alpha and IFN-gamma. Determination of interferon alpha (INF-alpha) and interferon gamma (INF-gamma) in human blood serum was carried out using flow cytometer. | Day 0 (baseline), 7, 14. |
| Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient) | Overall treatment efficacy. Evaluate the overall efficacy of the treatment by the investigator and by the participants. Results show the number of participants for each assessed category of the health status. | Day 3, 7, 14. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Full Range | kg/m^2 |
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| OG000 | Group 1 - Active Treatment - Amizon | 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). |
| OG001 | 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. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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). | Intention to treat | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Mean | Full Range | score on a 4-point Likert scale | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7, 14. |
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| 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.
A higher score implies worse clinical outcome. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Mean | Standard Error | score | Day 0 (baseline), 3, 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline). |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0 (baseline), 3, 7. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Mean | Standard Error | grams/liter | Day 0 (baseline), 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Mean | Standard Error | picograms/mL | Day 0 (baseline), 7, 14. |
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| 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. | Intention-to-treat. All randomized patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 3, 7, 14. |
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|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Group 2 - Placebo | Patient who were randomized into Group 2 ingested placebo tablets after a meal, at the dose 0.5 g (2 tablets), 3 times a day, for 7 days. Placebo: Patients ingested placebo tablets without chewing, after meal, in the dose 0.5 g (2 tablets), 3 times a day, for 7 days. | 0 | 40 | 0 | 40 | 3 | 40 |
| Heartburn | Gastrointestinal disorders | MedDRA 99.9 | Systematic Assessment |
|
| Burning sensation | Gastrointestinal disorders | MedDRA 99.9 | Systematic Assessment |
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| Acute respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA 99.9 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 99.9 | Systematic Assessment |
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| Allergic rash | Skin and subcutaneous tissue disorders | MedDRA 99.9 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 99.9 | Systematic Assessment |
|
Not provided
Not provided
| D012140 | Respiratory Tract Diseases |
| 2 days disability |
|
| > 2 days disability |
|
| Day 3 Patients who had no detectable viral antigens |
|
|
| Day 7 Patients who had no detectable viral antigens |
|
|
| Superiority |
| Study Day 7: |
|
| Study Day 14: |
|
| Superiority |
| Study Day 7: |
|
| Study Day 14: |
|
| MMRM |
| <0.0001 |
A mixed model repeated measurement was used, which considered baseline, treatment visit*treatment as fixed and patient as random effect. |
| Superiority |
| Day 14 | MMRM | <0.0001 | Superiority | A mixed model repeated measurement was used, which considered baseline, treatment visit*treatment as fixed and patient as random effect. |
| Study Day 7: Chills |
|
| Study Day 14: Chills |
|
| Study Day 7: Cough |
|
| Study Day 14: Cough |
|
| Superiority |
| Day 14 | Fisher Exact | <0.0001 | Superiority |
| Study Day 7: Patients without perceived elevated body temperature |
|
| Study Day 14: Patients without perceived elevated body temperature |
|
| Superiority |
| Day 14 | Fisher Exact | 0.4000 | Superiority |
| Study Day 7: Sore throat |
|
| Study Day 14: Sore throat |
|
| Superiority |
| Day 14 | Fisher Exact | 0.0363 | Superiority |
| Study Day 7: Headache |
|
| Study Day 14: Headache |
|
| Superiority |
| Day 14 | Fisher Exact | 0.0611 | Superiority |
| Study Day 7: Myalgia |
|
| Study Day 14: Myalgia |
|
| Study Day 7: Weakness |
|
| Study Day 14: Weakness |
|
| Superiority |
| Day 14 | Fisher Exact | 0.0277 | Superiority |
| Study Day 7 |
|
| Study Day 14 |
|
| Superiority |
| Day 14 | Fisher Exact | 0.4000 | Superiority |
| 37.1-37.5 |
|
| 36.6-37-0 |
|
| Study Day 3 |
|
| Study Day 7 |
|
| Study Day 14 |
|
| Study Day 7 |
|
| Study Day 14 |
|
| Study Day 7 |
|
| Study Day 14 |
|
| Superiority |
| Day 14 | Fisher Exact | 0.0064 | Superiority |
| Moderate |
|
| Severe |
|
| Study Day 3 |
|
| Study Day 7 |
|
| Study Day 14 |
|
| Study Day 7: |
|
| Study Day 14: |
|
| 0.036 |
| Superiority |
| Day 14 | Wilcoxon (Mann-Whitney) | <0.0001 | Superiority |
| Influenza B |
|
| Adenovirus (Mono) |
|
| Influenza A and Adenovirus (Combination of antigens) |
|
| Parainfluenza (Mono) |
|
| Respiratory syncytial virus (Mono) |
|
| Non-differentiated acute respiratory viral infection (ARVI) |
|
| Day 3 Patients who had no detectable viral antigen |
|
|
| Day 7 Patients who had no detectable viral antigen |
|
|
| Superiority |
| Day 7 Patients who had no detectable viral antigens |
|
| Superiority |
| Day 7 Patients who had no detectable viral antigen |
|
| Superiority |
| Day 3 Patients who had no detectable viral antigen |
|
|
| Day 7 Patients who had no detectable viral antigen |
|
|
| Superiority |
| Day 7 Patients who had no detectable viral antigens |
|
| Superiority |
| Day 0, IgG |
|
| Day 7, IgA |
|
| Day 7, IgM |
|
| Day 7, IgG |
|
| Day 14, IgA |
|
| Day 14, IgM |
|
| Day 14, IgG |
|
| Day 7, IFN-alpha |
|
| Day 7, IFN-gamma |
|
| Day 14, IFN-alpha |
|
| Day 14, IFN-gamma |
|
| 0.943 |
| Superiority |
| Day 7, IFN-alpha | Fisher Exact | <0.001 | Superiority |
| Day 7, IFN-gamma | Fisher Exact | <0.001 | Superiority |
| Day 14, IFN-alpha | Fisher Exact | 0.625 | Superiority |
| Day 14, IFN-gamma | Fisher Exact | <0.001 | Superiority |
| Moderate improve |
|
| No significant change |
|
| Worsened |
|
| Day 3: Patient |
|
| Day 7: Investigator |
|
| Day 7: Patient |
|
| Day 14: Investigator |
|
| Day 14: Patient |
|