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

• Status: Completed
• Trial end date: 2019-12-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NPO Petrovax

Criteria

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.