| Primary | Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days) | Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever | | Posted | | Mean | 95% Confidence Interval | day | | Day 8±1 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.04(1.74 to 2.34)
- OG0012.26(2.03 to 2.50)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning). | t-test, 2 sided | | <0.05 | | Mean Difference (Final Values) | -0.22 | | | 2-Sided | 95 | -0.6 | 0.16 | | | | | Superiority | | |
|
| Secondary | Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) | A total number of patients (NP) without symptoms due to "General intoxication symptoms" domain of the Symptom Assessment Scale (SAS) was evaluated. A total number of patients (NP) with mild symptoms due to "General intoxication symptoms" domain of SAS (1 point according SAS) was evaluated. A total number of patients (NP) with moderate symptoms due to "General intoxication symptoms" domain of SAS (2 point according SAS) was be evaluated. A total number of patients (NP) with severe symptoms due to "General intoxication symptoms" domain of SAS (3 point according SAS) was evaluated. Domain "General intoxication symptoms" includes the following symptoms:
- altered/decreased activity;
- altered appetite;
- unhealthy appearance;
- altered or interrupted sleep.
Each symptom may be graded by the following points:
- 0 points - absent;
- 1 point - mild;
- 2 points - moderate;
- 3 points - severe.
| | Posted | | Count of Participants | | Participants | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 sublingual spray 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 intranasal spray (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 intranasal spray (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 intranasal spray (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment | Each symptom was graded by the following points:
- 0 points - absent;
- 1 point - mild;
- 2 points - moderate;
- 3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)
| | Posted | | Count of Participants | | Participants | | Day 3, Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | |
|
| Secondary | Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment | Each symptom was graded by the following points:
- 0 points - absent;
- 1 point - mild;
- 2 points - moderate;
- 3 points - severe. The higher scores mean worse outcome. The maximum score is 3 points, the minimum score is 0 points.
| | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 3, Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment | Symptom Assessment Scale (SAS) consists of 3 domains:
- Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
- "Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing);
- "Throat and thoracic symptoms" (hoarseness; sore throat; cough).
Each symptom may be graded by the following points:
- 0 points - absent;
- 1 point - mild;
- 2 points - moderate;
- 3 points - severe. The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
| | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 3, Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 |
|
| Secondary | Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator | Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition: 0 points - absolute recovery;
- point - significant improvement;
- points - slight to moderate improvement;
- points - unchanged;
- points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
| | Posted | | Count of Participants | | Participants | | Day 8±1 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter | Integrative Medicine Outcome Scale (IMOS) is used to assess treatment efficacy and has the following gradations of health condition: 0 points - absolute recovery;
- point - significant improvement;
- points - slight to moderate improvement;
- points - unchanged;
- points - decline. The results is presented in number of patients with 0 points (absolute recovery), number of patients with 1 points (significant improvement), number of patients with 2 points (slight to moderate improvement), number of patients with 3 points (unchanged), number ot patients with 4 points (decline) by day 8 according IMOS.
| | Posted | | Count of Participants | | Participants | | Day 8±1 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Number of Cases of Antifebrile Agents Use | Number of cases of the antipyretic product (paracetamol) consumption for the entire study period | | Posted | | Count of Participants | | Participants | | Day 8±1 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy | Number of patients who discontinued from the study due to requirement for antibacterial therapy | | Posted | | Count of Participants | | Participants | | Day 8±1 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Number of Patients With Normalization of Body Temperature by 5 Day of Treatment | Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature | | Posted | | Count of Participants | | Participants | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 | Placebo | Placebo, nasal and sublingual spray - 7 days. Placebo: Placebo nasal and sublingual spray will be administered for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). |
|
| Secondary | Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment | Symptom Assessment Scale (SAS) consists of 3 domains:
- Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep);
- "Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing);
- "Throat and thoracic symptoms" (hoarseness; sore throat; cough). The higher scores mean a worse outcome. The total score is the sum of points of each symptom graded in Symptom Assessment Scale. The maximum possible value of the total score is 30 points, the minimum possible value of the total score is 0 points.
Each symptom may be graded by the following points:
- 0 points - absent;
- 1 point - mild;
- 2 points - moderate;
- 3 points - severe.
| | Posted | | Count of Participants | | Participants | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Polyoxidonium 6 mg/ml | Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. Polyoxidonium 6 mg/ml: Nasal and sublingual spray Polyoxidonium 6 mg/ml was administered at a dose of 0,15 mg/kg daily for 7 days: in children aged from 1 to 2 years - 1 spray 2 times a day sublingually (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours); in children aged from 5 to 8 years - 1 spay intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spay intranasally (in each nasal passage) 2 times a day (every 12 hours). | | OG001 |
|