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

NPO Petrovax172 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

172

Conditions

Acute Respiratory Infection

Interventions

Polyoxidonium 6 mg/mlDRUG

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).

PlaceboOTHER

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).

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (11)

Medical Center "Medical Technology"

Saint Petersburg, Leningradskaya Oblast', Russia

Medical Center "MedAestheticCentre Laboratory"

Saint Petersburg, Leningradskaya Oblast', Russia

Medical center "Curator"

Saint Petersburg, Leningradskaya Oblast', Russia

Outcomes

Primary Outcomes

Fever Duration (With a Superiority Cut-off Level δ=-0,52 Days)

Normalization of body temperature (axillary body temperature level ≤ 36,9 °C confirmed by two consecutive measurements (morning-evening/evening-morning)) will be considered as the end of fever

Time frame: Day 8±1

Secondary Outcomes

Changes in Intoxication Symptoms by 3 Day of Treatment Due to Symptom Assessment Scale (SAS)

A total number of patients (NP) without symptoms due to "General intoxication symptoms" domain of the Symptom Assessment Scale (SAS) was evaluated. A total number of patients (NP) with mild symptoms due to "General intoxication symptoms" domain of SAS (1 point according SAS) was evaluated. A total number of patients (NP) with moderate symptoms due to "General intoxication symptoms" domain of SAS (2 point according SAS) was be evaluated. A total number of patients (NP) with severe symptoms due to "General intoxication symptoms" domain of SAS (3 point according SAS) was evaluated. Domain "General intoxication symptoms" includes the following symptoms: * altered/decreased activity; * altered appetite; * unhealthy appearance; * altered or interrupted sleep. Each symptom may be graded by the following points: * 0 points - absent; * 1 point - mild; * 2 points - moderate; * 3 points - severe.

Time frame: Day 3

Number of Patients (NP) Without Nasal Discharge Symptom by 3 and 5 Day of Treatment, Number of Patients (NP) With Mild/Moderate/Severe Nasal Discharge Symptom by 3 and 5 Day of Treatment

Each symptom was graded by the following points: * 0 points - absent; * 1 point - mild; * 2 points - moderate; * 3 points - severe. Number of patients (NP) without nasal discharge symptom by 3 and 5 day of treatment (score on the scale 0 point), Number of patients (NP) with mild nasal discharge symptom by 3 and 5 day of treatment (score on the scale 1 points) Number of patients (NP) with moderate nasal discharge symptom by 3 and 5 day of treatment (score on the scale 2 points) Number of patients (NP) with severe nasal discharge symptom by 3 and 5 day of treatment (score on the scale 3 points)

Time frame: Day 3, Day 5

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.