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

PHASE3CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

February 26, 2019

Study Completion Date

December 10, 2019

Conditions
Acute Respiratory Infection
Interventions
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

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)."

Trial Locations (11)

123182

Scientific Clinical Center of Otorhinolaryngology of the Federal Medical and Biological Agency, Moscow

143300

"Medical center Korolev Medicine", Naro-Fominsk

150000

Yaroslavl State Medical University, Yaroslavl

150042

Regional Children's Clinical Hospital, Yaroslavl

192148

"Medical Center Medical Technology", Saint Petersburg

192177

"Medical Center MedAestheticCentre Laboratory", Saint Petersburg

196240

"Medical center Curator", Saint Petersburg

196657

Children's City Hospital No. 22, Saint Petersburg

197376

"Federal state budgetary institution Research Institute of Influenza of Ministry of Health of Russia", Saint Petersburg

344065

Children's City Clinic №4 of the city of Rostov-on-Don, Rostov-on-Don

614066

City Children's Clinical Clinic №5, Perm

All Listed Sponsors
lead

NPO Petrovax

INDUSTRY

NCT03840135 - Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI | Biotech Hunter | Biotech Hunter