Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Sponsor
NPO Petrovax (Industry)
Overall Status
Completed
CT.gov ID
NCT03840135
Collaborator
(none)
172
11
2
13.1
15.6
1.2
Study Details
Study Description
Brief Summary
The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute respiratory viral infections. This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute respiratory viral infections symptoms in children population. A study will last for 13 days (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3, Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude subjects with influenza or streptococcal infection. All eligible subjects will be treated with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected at days 1, 3, 8 ±1 and 12 ±1.
Study Design
Study Type:
Interventional
Actual Enrollment
:
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged From 1 to 12 Years With ARI (Acute Respiratory Infection)
Actual Study Start Date
:
Nov 7, 2018
Actual Primary Completion Date
:
Feb 26, 2019
Actual Study Completion Date
:
Dec 10, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Polyoxidonium 6 mg/ml Polyoxidonium 6 mg/ml nasal and sublingual spray - 0,15 mg/kg daily - 7 days. |
Drug: 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).
Other Names:
|
| Placebo Comparator: Placebo Placebo, nasal and sublingual spray - 7 days. |
Other: 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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days) [Day 8±1]
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
Secondary Outcome Measures
- Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) [Day 3]
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.
- 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 [Day 3, Day 5]
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)
- Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment [Day 3, Day 5]
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.
- Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment [Day 3, Day 5]
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.
- Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator [Day 8±1]
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.
- Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter [Day 8±1]
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.
- Number of Cases of Antifebrile Agents Use [Day 8±1]
Number of cases of the antipyretic product (paracetamol) consumption for the entire study period
- Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy [Day 8±1]
Number of patients who discontinued from the study due to requirement for antibacterial therapy
- Number of Patients With Normalization of Body Temperature by 5 Day of Treatment [Day 5]
Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature
- Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment [Day 5]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female patients aged 1 to 12 years
-
Diagnosis of acute respiratory viral infection [International Classification of Diseases (10-th revision) codes: Acute nasopharyngitis [common cold], J02 Acute pharyngitis, J02.9 Acute pharyngitis, unspecified, J04 Acute laryngitis and tracheitis, J04.0 Acute laryngitis, J04.1 Acute tracheitis, J04.2 Acute laryngotracheitis, J06 Acute upper respiratory infections of multiple and unspecified sites, J06.0 Acute laryngopharyngitis, J06.9 Acute upper respiratory infection, unspecified] confirmed by physical examination: axillary temperature ≥ 37,0°C (measured at the moment of physical examination) and Symptoms Assessment Scale total score ≥5 points (not less than 3 of which should be related to ear, or nose, or throat, or upper respiratory tract affection symptoms).
-
Less than 24 hours from the onset of disease (first respiratory viral infection symptoms)
-
Informed consent signed by parent/adopter, or a child (applicable for children aged > 10 years)
Exclusion Criteria:
-
Suspicion on pneumonia, bacterial infection (including meningitis, sepsis, otitis media, sinusitis, sinusitis, urinary tract infection etc.) or a condition that requires antibacterial therapy from the first day of treatment.
-
Suspicion on other diseases that may simulate acute respiratory viral infection at the moment of onset (other infectious diseases, flu-like syndrome in system collagen and other diseases).
-
Positive express test for influenza or streptococcal infection.
-
Clinical signs of serious acute respiratory viral infection, which requires hospitalization (fever ≥ 40°C, sings of airway obstruction, significant hemodynamic or neurological disorders).
-
History of primary or secondary immunodeficiency.
-
Cancer.
-
Acute infectious and non-infectious diseases (except acute respiratory viral infection), exacerbation or decompensation of chronic diseases (diabetes mellitus, infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of upper respiratory tract,ears, nose, or throat) which may affect an ability of patient to participate in study.
-
Saccharase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
-
History of allergy/hypersensitivity to any component of the study drug (including paracetamol, propacetamol hydrochloride).
-
Use of protocol-prohibited medications within 1 month prior to study.
-
Children, who's parents/adopters may fail to follow the protocol procedures and treatment, in investigator's opinion.
-
Participation in other studies within 3 months to screening.
-
Pregnancy.
-
Any other medical or social condition that may interrupt study participation, in investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Center "Medical Technology" | Saint Petersburg | Leningrad Region | Russian Federation | 192148 |
| 2 | Medical Center "MedAestheticCentre Laboratory" | Saint Petersburg | Leningrad Region | Russian Federation | 192177 |
| 3 | Medical center "Curator" | Saint Petersburg | Leningrad Region | Russian Federation | 196240 |
| 4 | Children's City Hospital No. 22 | Saint Petersburg | Leningrad Region | Russian Federation | 196657 |
| 5 | Medical center "Korolev Medicine" | Naro-Fominsk | Moscow Region | Russian Federation | 143300 |
| 6 | City Children's Clinical Clinic №5 | Perm' | Perm Region | Russian Federation | 614066 |
| 7 | Children's City Clinic №4 of the city of Rostov-on-Don | Rostov-on-Don | Rostov Region | Russian Federation | 344065 |
| 8 | Yaroslavl State Medical University | Yaroslavl | Yaroslavl Region | Russian Federation | 150000 |
| 9 | Regional Children's Clinical Hospital | Yaroslavl | Yaroslavl Region | Russian Federation | 150042 |
| 10 | Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency | Moscow | Russian Federation | 123182 | |
| 11 | Federal state budgetary institution "Research Institute of Influenza" of Ministry of Health of Russia | Saint-Petersburg | Russian Federation | 197376 |
Sponsors and Collaborators
- NPO Petrovax
Investigators
- Study Chair: Nikolai Dodonov, NPO Petrovax
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
NPO Petrovax
ClinicalTrials.gov Identifier:
NCT03840135
Other Study ID Numbers:
- PoArvi/PhIII_2017
First Posted:
Feb 15, 2019
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NPO Petrovax
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Period Title: Overall Study | ||
| STARTED | 86 | 86 |
| COMPLETED | 79 | 85 |
| NOT COMPLETED | 7 | 1 |
Baseline Characteristics
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | Total of all reporting groups |
| Overall Participants | 76 | 79 | 155 |
| Age (Count of Participants) | |||
| <=18 years |
76
100%
|
79
100%
|
155
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
6
|
5
|
5
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
33
43.4%
|
41
51.9%
|
74
47.7%
|
| Male |
43
56.6%
|
38
48.1%
|
81
52.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
1.3%
|
1
1.3%
|
2
1.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
75
98.7%
|
78
98.7%
|
153
98.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Russia |
76
100%
|
79
100%
|
155
100%
|
| Body Mass (kg) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [kg] |
20.85
|
18
|
19
|
| Body height (m) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [m] |
1.16
|
1.12
|
1.13
|
Outcome Measures
| Title | Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days) |
|---|---|
| Description | 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 |
| Time Frame | Day 8±1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Mean (95% Confidence Interval) [day] |
2.04
|
2.26
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | 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). | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.6 to 0.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) |
|---|---|
| Description | 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. |
| Time Frame | Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| NP without altered/decreased activity day 0 |
14
18.4%
|
11
13.9%
|
| NP with mild altered/decreased activity day 0 |
40
52.6%
|
51
64.6%
|
| NP with moderate altered/decreased activity day 0 |
22
28.9%
|
17
21.5%
|
| NP with severe altered/decreased activity day 0 |
0
0%
|
0
0%
|
| NP without altered/decreased activity day 3 |
52
68.4%
|
46
58.2%
|
| NP with mild altered/decreased activity day 3 |
23
30.3%
|
33
41.8%
|
| NP with moderate altered/decreased activity day 3 |
1
1.3%
|
0
0%
|
| NP with severe altered/decreased activity day 3 |
0
0%
|
0
0%
|
| NP without altered appetite day 0 |
9
11.8%
|
10
12.7%
|
| NP with mild altered appetite day 0 |
35
46.1%
|
44
55.7%
|
| NP with moderate altered appetite day 0 |
31
40.8%
|
25
31.6%
|
| NP with severe altered appetite day 0 |
1
1.3%
|
0
0%
|
| NP without altered appetite day 3 |
54
71.1%
|
50
63.3%
|
| NP with mild altered appetite day 3 |
18
23.7%
|
27
34.2%
|
| NP with moderate altered appetite day 3 |
4
5.3%
|
2
2.5%
|
| NP with severe altered appetite day 3 |
0
0%
|
0
0%
|
| NP without unhealthy appearance day 0 |
8
10.5%
|
6
7.6%
|
| NP with mild unhealthy appearance day 0 |
50
65.8%
|
56
70.9%
|
| NP with moderate unhealthy appearance day 0 |
18
23.7%
|
17
21.5%
|
| NP with severe mild unhealthy appearance day 0 |
0
0%
|
0
0%
|
| NP without unhealthy appearance day 3 |
59
77.6%
|
49
62%
|
| NP with mild unhealthy appearance day 3 |
16
21.1%
|
30
38%
|
| NP with moderate unhealthy appearance day 3 |
1
1.3%
|
0
0%
|
| NP with severe unhealthy appearance day 3 |
0
0%
|
0
0%
|
| NP without altered or interrupted sleep day 0 |
40
52.6%
|
46
58.2%
|
| NP with mild altered or interrupted sleep day 0 |
23
30.3%
|
27
34.2%
|
| NP with moderate altered or interrupt. sleep day 0 |
13
17.1%
|
6
7.6%
|
| NP with severe altered or interrupt. sleep day 0 |
0
0%
|
0
0%
|
| NP without altered or interrupted sleep day 3 |
73
96.1%
|
71
89.9%
|
| NP with mild altered or interrupted sleep day 3 |
3
3.9%
|
6
7.6%
|
| NP with moderate altered or interrupt. sleep day 3 |
0
0%
|
2
2.5%
|
| NP with severe altered or interrupt. sleep day 3 |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | χ2 Pearson criterion | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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) |
| Time Frame | Day 3, Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| NP without nasal discharge symptom |
9
11.8%
|
12
15.2%
|
| NP with mild nasal discharge symptom |
19
25%
|
20
25.3%
|
| NP with moderate nasal discharge symptom |
46
60.5%
|
43
54.4%
|
| NP with severe nasal discharge symptom |
2
2.6%
|
4
5.1%
|
| NP without nasal discharge symptom |
26
34.2%
|
13
16.5%
|
| NP with mild nasal discharge symptom |
30
39.5%
|
37
46.8%
|
| NP with moderate nasal discharge symptom |
20
26.3%
|
29
36.7%
|
| NP with severe nasal discharge symptom |
0
0%
|
0
0%
|
| NP without nasal discharge symptom |
40
52.6%
|
24
30.4%
|
| NP with mild nasal discharge symptom |
29
38.2%
|
38
48.1%
|
| NP with moderate nasal discharge symptom |
7
9.2%
|
17
21.5%
|
| NP with severe nasal discharge symptom |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | χ2 Pearson criterion | |
| Comments | ||
| Title | Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment |
|---|---|
| Description | 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. |
| Time Frame | Day 3, Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| nasal discharge day 0 |
2
|
2
|
| nasal discharge by day 3 |
1
|
1
|
| nasal discharge by day 5 |
0
|
1
|
| nasal congestion/impaired nasal airflow by day 0 |
2
|
2
|
| nasal congestion/impaired nasal airflow by day 3 |
1
|
1
|
| nasal congestion/impaired nasal airflow by day 5 |
0
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | χ2 Pearson criterion | |
| Comments | ||
| Title | Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment |
|---|---|
| Description | 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. |
| Time Frame | Day 3, Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Day 0 |
11
|
10
|
| Day 3 |
4.00
|
5.00
|
| Day 5 |
1.00
|
3.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator |
|---|---|
| Description | 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. |
| Time Frame | Day 8±1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| absolute recovery |
62
81.6%
|
60
75.9%
|
| significant improvement |
12
15.8%
|
14
17.7%
|
| slight to moderate improvement |
2
2.6%
|
4
5.1%
|
| unchanged |
0
0%
|
1
1.3%
|
| decline |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | χ2 Pearson criterion | |
| Comments | ||
| Title | Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter |
|---|---|
| Description | 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. |
| Time Frame | Day 8±1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| absolute recovery |
41
53.9%
|
35
44.3%
|
| significant improvement |
30
39.5%
|
30
38%
|
| slight to moderate improvement |
5
6.6%
|
9
11.4%
|
| unchanged |
0
0%
|
5
6.3%
|
| decline |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | χ2 Pearson criterion | |
| Comments | ||
| Title | Number of Cases of Antifebrile Agents Use |
|---|---|
| Description | Number of cases of the antipyretic product (paracetamol) consumption for the entire study period |
| Time Frame | Day 8±1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Count of Participants [Participants] |
8
10.5%
|
10
12.7%
|
| Title | Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy |
|---|---|
| Description | Number of patients who discontinued from the study due to requirement for antibacterial therapy |
| Time Frame | Day 8±1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Patients With Normalization of Body Temperature by 5 Day of Treatment |
|---|---|
| Description | Axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning will be considered as normalization of body temperature |
| Time Frame | Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Count of Participants [Participants] |
73
96.1%
|
76
96.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment |
|---|---|
| Description | 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. |
| Time Frame | Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 76 | 79 |
| Count of Participants [Participants] |
56
73.7%
|
51
64.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Polyoxidonium 6 mg/ml, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | 12±1 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Among 172 randomized patients, 2 patients did not take the study drug for reasons of non-compliance with inclusion criterion No. 3 and withdrawal of informed consent, respectively. Thus, the safety analysis included data from 170 patients (84 in the study drug group and 86 in the comparison drug group) who were included in the study and took the drug at least once. | |||
| Arm/Group Title | Polyoxidonium 6 mg/ml | Placebo | ||
| Arm/Group Description | 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). | 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). | ||
All Cause Mortality |
||||
| Polyoxidonium 6 mg/ml | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | 0/86 (0%) | ||
Serious Adverse Events |
||||
| Polyoxidonium 6 mg/ml | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | 0/86 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Polyoxidonium 6 mg/ml | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/84 (1.2%) | 6/86 (7%) | ||
| Ear and labyrinth disorders | ||||
| acute catarrhal otitis media on the left | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 |
| acute purulent otitis media on the left | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 |
| acute otitis media | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 |
| Gastrointestinal disorders | ||||
| loose stool | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 |
| Investigations | ||||
| nose bleed | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| bronchitis | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nikolay Dodonov, Head of medical department |
|---|---|
| Organization | NPO Petrovax Pharm, LLC |
| Phone | +7(495) 730-75-45 ext 125 |
| DodonovNS@petrovax.ru |
Responsible Party:
NPO Petrovax
ClinicalTrials.gov Identifier:
NCT03840135
Other Study ID Numbers:
- PoArvi/PhIII_2017
First Posted:
Feb 15, 2019
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020