Trial Outcomes & Findings for Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI (NCT NCT03840135)

Last Updated: 2020-07-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

172 participants

Primary outcome timeframe

Day 8±1

Results posted on

2020-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	86	86
Overall Study COMPLETED	79	85
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Protocol Violation	6	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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 n=155 Participants Total of all reporting groups
Age, Categorical <=18 years	76 Participants n=5 Participants	79 Participants n=7 Participants	155 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	6 years n=5 Participants	5 years n=7 Participants	5 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	41 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	78 Participants n=7 Participants	153 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	76 participants n=5 Participants	79 participants n=7 Participants	155 participants n=5 Participants
Body Mass	20.85 kg n=5 Participants	18 kg n=7 Participants	19 kg n=5 Participants
Body height	1.16 m n=5 Participants	1.12 m n=7 Participants	1.13 m n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)	2.04 day Interval 1.74 to 2.34	2.26 day Interval 2.03 to 2.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered/decreased activity day 0	14 Participants	11 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered/decreased activity day 0	40 Participants	51 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered/decreased activity day 0	22 Participants	17 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered/decreased activity day 0	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered/decreased activity day 3	52 Participants	46 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered/decreased activity day 3	23 Participants	33 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered/decreased activity day 3	1 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered/decreased activity day 3	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered appetite day 0	9 Participants	10 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered appetite day 0	35 Participants	44 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered appetite day 0	31 Participants	25 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered appetite day 0	1 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered appetite day 3	54 Participants	50 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered appetite day 3	18 Participants	27 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered appetite day 3	4 Participants	2 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered appetite day 3	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without unhealthy appearance day 0	8 Participants	6 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild unhealthy appearance day 0	50 Participants	56 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate unhealthy appearance day 0	18 Participants	17 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe mild unhealthy appearance day 0	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without unhealthy appearance day 3	59 Participants	49 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild unhealthy appearance day 3	16 Participants	30 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate unhealthy appearance day 3	1 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe unhealthy appearance day 3	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered or interrupted sleep day 0	40 Participants	46 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered or interrupted sleep day 0	23 Participants	27 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered or interrupt. sleep day 0	13 Participants	6 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered or interrupt. sleep day 0	0 Participants	0 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP without altered or interrupted sleep day 3	73 Participants	71 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with mild altered or interrupted sleep day 3	3 Participants	6 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with moderate altered or interrupt. sleep day 3	0 Participants	2 Participants
Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS) NP with severe altered or interrupt. sleep day 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
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 0 · NP without nasal discharge symptom	9 Participants	12 Participants
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 0 · NP with mild nasal discharge symptom	19 Participants	20 Participants
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 0 · NP with moderate nasal discharge symptom	46 Participants	43 Participants
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 0 · NP with severe nasal discharge symptom	2 Participants	4 Participants
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 · NP without nasal discharge symptom	26 Participants	13 Participants
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 · NP with mild nasal discharge symptom	30 Participants	37 Participants
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 · NP with moderate nasal discharge symptom	20 Participants	29 Participants
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 · NP with severe nasal discharge symptom	0 Participants	0 Participants
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 5 · NP without nasal discharge symptom	40 Participants	24 Participants
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 5 · NP with mild nasal discharge symptom	29 Participants	38 Participants
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 5 · NP with moderate nasal discharge symptom	7 Participants	17 Participants
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 5 · NP with severe nasal discharge symptom	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal congestion/impaired nasal airflow by day 5	0 score on a scale Interval 0.0 to 1.0	1 score on a scale Interval 0.0 to 1.0
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal discharge day 0	2 score on a scale Interval 1.0 to 2.0	2 score on a scale Interval 1.0 to 2.0
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal discharge by day 3	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 1.0 to 2.0
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal discharge by day 5	0 score on a scale Interval 0.0 to 1.0	1 score on a scale Interval 0.0 to 1.0
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal congestion/impaired nasal airflow by day 0	2 score on a scale Interval 2.0 to 2.0	2 score on a scale Interval 1.0 to 2.0
Score on Symptoms: Nasal Discharge and Nasal Congestion/Impaired Nasal Airflow Due to Symptom Assessment Scale by 3 and 5 Day of Treatment nasal congestion/impaired nasal airflow by day 3	1 score on a scale Interval 0.0 to 1.0	1 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Day 3, Day 5

Symptom Assessment Scale (SAS) consists of 3 domains: 1. Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep); 2. "Nose symptoms" (nasal discharge; nasal congestion/impaired nasal airflow; sneezing); 3. "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.

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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 Score on Symptom Assessment Scale by 3 and 5 Day of Treatment Day 0	11 score on a scale Interval 8.0 to 14.0	10 score on a scale Interval 8.0 to 13.0
Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment Day 3	4.00 score on a scale Interval 2.0 to 6.0	5.00 score on a scale Interval 3.0 to 7.0
Total Score on Symptom Assessment Scale by 3 and 5 Day of Treatment Day 5	1.00 score on a scale Interval 0.0 to 4.0	3.00 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 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; 1. point - significant improvement; 2. points - slight to moderate improvement; 3. points - unchanged; 4. 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.

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator absolute recovery	62 Participants	60 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator significant improvement	12 Participants	14 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator slight to moderate improvement	2 Participants	4 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator unchanged	0 Participants	1 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Investigator decline	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 8±1

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter absolute recovery	41 Participants	35 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter significant improvement	30 Participants	30 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter slight to moderate improvement	5 Participants	9 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter unchanged	0 Participants	5 Participants
Assessment of Treatment Results With Integrative Medicine Outcome Scale (IMOS) Performed by Parent/Adopter decline	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 8±1

Number of cases of the antipyretic product (paracetamol) consumption for the entire study period

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Number of Cases of Antifebrile Agents Use	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 8±1

Number of patients who discontinued from the study due to requirement for antibacterial therapy

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Number of Patients Discontinued From the Study Due to Requirement for Antibacterial Therapy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Number of Patients With Normalization of Body Temperature by 5 Day of Treatment	73 Participants	76 Participants

SECONDARY outcome

Timeframe: Day 5

Symptom Assessment Scale (SAS) consists of 3 domains: 1. Domain "General intoxication symptoms" (altered/increased activity/dysfunctional behavior; altered appetite or food refusal; unhealthy or alter from common appearance; altered or interrupted sleep); 2. "Nose symptoms" (nasal discharge; nasal congestion; impaired nasal airflow; sneezing); 3. "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.

Outcome measures

Outcome measures
Measure	Polyoxidonium 6 mg/ml n=76 Participants 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 n=79 Participants 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).
Number of Patients With Clinical Improvement (Symptom Assessment Scale Total Score ≤ 3) by 5 Day of Treatment	56 Participants	51 Participants

Adverse Events

Polyoxidonium 6 mg/ml

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Polyoxidonium 6 mg/ml n=84 participants at risk 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 n=86 participants at risk 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).
Ear and labyrinth disorders acute catarrhal otitis media on the left	1.2% 1/84 • Number of events 1 • 12±1 days 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.	0.00% 0/86 • 12±1 days 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.
Ear and labyrinth disorders acute purulent otitis media on the left	0.00% 0/84 • 12±1 days 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.	1.2% 1/86 • Number of events 1 • 12±1 days 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.
Gastrointestinal disorders loose stool	0.00% 0/84 • 12±1 days 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.	2.3% 2/86 • Number of events 2 • 12±1 days 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.
Ear and labyrinth disorders acute otitis media	0.00% 0/84 • 12±1 days 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.	1.2% 1/86 • Number of events 1 • 12±1 days 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.
Investigations nose bleed	0.00% 0/84 • 12±1 days 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.	1.2% 1/86 • Number of events 1 • 12±1 days 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.
Respiratory, thoracic and mediastinal disorders bronchitis	0.00% 0/84 • 12±1 days 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.	1.2% 1/86 • Number of events 1 • 12±1 days 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.

Additional Information

Nikolay Dodonov, Head of medical department

NPO Petrovax Pharm, LLC

Phone: +7(495) 730-75-45

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place