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A Multicenter, Prospective, Randomized, Double Protocol No. PoArvi/PhIII_2017 Sponsor: NPO Petrovax Pharm LLC, Russia Version: 2.0 of 30/05/2018 CLINICAL PROTOCOL Protocol No.: PoArvi/PhIII 2017 Version: 2.0 of 30/05/2018 "A multicenter, prospective, randomized, double-blind, placebo- controlled parallel-group study of the efficacy and safety of Polyoxidonium®, nasal and sublingual spray, 6 mg/ml (NPO Petrovax Pharm LLC, Russia) in children aged 1 to 12 years with a diagnosis of acute respiratory viral infections (ARVI)" Study Sponsor: NPO Petrovax Pharm LLC, Russia Address: 1 Sosnovaya st., Pokrov village, Podolsk, Moscow Oblast, Russia, 142143 Confidentiality Statement The confidential information contained herein is provided to you as the Principal Investigator or Consultant for review by you, your employees and the relevant Supervisory Board of the organization/Independent Ethics Committee. Y our acceptance of this document means your consent to non-disclosure of the information contained in it to other persons without the written permission of the Sponsor/Representative of the Sponsor, except for the information necessary to obtain the Informed Consent from the persons participating in this study. MOSCOW, 2018 Confidential Page 1 of 128 Protocol No. PoArvi/PhIII_2017 Sponsor: NPO Petrovax Pharm LLC, Russia Version: 2.0 of 30/05/2018 1. PROTOCOL SYNOPSIS Sponsor of the study NPO Petrovax Pharm LLC, Russia Study title A multicenter, prospective, randomized, double-blind, placebo- controlled study of the efficacy and safety of Polyoxidonium®, nasal and sublingual spray, 6 mg/ml (NPO Petrovax Pharm LLC, Russia) in children aged 1 to 12 years with a diagnosis of ARVI. Protocol No. PoArvi/PhIII 2017 Date/Version No. 2.0 of 30/05/2018 Study phase III (study of the product safety and efficacy in subjects with a particular disease) Study product and Study product: Polyoxidonium®, nasal and sublingual spray, 6 mg/ml Comparator (NPO Petrovax Pharm, LLC, Russia). Composition per 1 ml: Active ingredient: Azoximer bromide - 6 mg Excipients: mannitol - 1.8 mg, Povidone K 17 - 1.2 mg, purified water - up to 1.0 ml Placebo: nasal and sublingual spray (NPO Petrovax Pharm LLC, Russia). Composition per 1 ml: Excipients: mannitol - 1.8 mg, Povidone K 17 - 1.2 mg, purified water - up to 1.0 ml Study design A multicenter, prospective, randomized, double-blind, parallel-group placebo-controlled Phase III study of efficacy and safety. Posology and method of Study product: every day, at a daily dose of 0.15 mg/kg for 7 days: administration - for children aged 1 to 2 years: 1 spray x 2 times a day, sublingual; - for children aged 2 to 5 years: 1 spray x 2 times a day, intranasal into each nostril; - for children aged 5 to 8 years: 1 spray x 3 times a day, intranasal into each nostril; - for children aged 8 to 12 years: 2 sprays x 2 times a day, intranasal into each nostril. Placebo is administered the same way as the study product The first dose of study drug/placebo is administered at Visit 1 (or Visit 0, if it is combined with Visit 1). Subsequent doses are received at fixed time intervals: 12 ± 2 h - with 2-times a day administration of the SP/placebo; 8 ± 1 h - with 3- times a day administration of the SP/placebo Study design A multicenter, prospective, randomized, double-blind, parallel group placebo-controlled Phase III study of efficacy and safety. Confidential Page 2 of 128 Protocol No. PoArvi/PhIII_2017 Sponsor: NPO Petrovax Pharm LLC, Russia Version: 2.0 of 30/05/2018 Study purpose The main purpose of this study is to demonstrate the superiority of Polyoxidonium®, nasal and sublingual spray, 6 mg/ml (NPO Petrovax Pharm LLC, Russia) therapeutic benefits over placebo in regards to therapy efficacy, when used as part of complex therapy in children aged 1 to 12 years with a diagnosis of ARVI after 7 days of treatment. Study objectives 1. To demonstrate the superiority of Polyoxidonium®, nasal and sublingual spray, 6 mg/ml (NPO Petrovax Pharm, LLC, Russia) efficacy profile over placebo, when used as part of complex therapy in children aged 1 to 12 years with a diagnosis of ARVI. 2. To evaluate the safety of the study product Polyoxidonium®, nasal and sublingual spray, 6 mg/ml (NPO Petrovax Pharm, LLC, Russia) compared with placebo as part of complex therapy in children aged 1 to 12 years with a diagnosis of ARVI. Study duration Anticipated total duration of enrollment period will be up to 6 months in all clinical centers is; this means that the period from the date of inclusion of the first patient to the last visit of the last patient will be 6 months. According to the Protocol schedule, the duration of study participation will be at most 13 days for each subject. Furthermore according to Protocol the subject may be enrolled into the study only within 24 hours from the onset of ARVI manifestationsDue to the seasonal nature of the disease, the clinical part of the study is supposed to be carried out between September 2018 and February 2019. Visit 0 (screening) - Day -1... Day 0 (within 24 hours from the onset of ARVI symptoms). Visit 1 - Day 1 (randomization, Visit can be combined with Visit 0). Visit 2 - Day 3 - assessment of the clinical pattern dynamics, exclusion the need for the antibacterial therapy prescription. Visit 3 - Day 8 ± 1 - safety control, assessment of the clinical pattern dynamics, exclusion of the complications available. Visit 4 (telephone contact) - Day 12 ± 1 - follow-up period. Duration of study participation will be at most 13 days for each subject. Anticipated duration of the entire study will be approximately 9 months: Recruitment period will last for 6 months; data analylis and the Final Report preparation will last about 3 months. Confidential Page 3 of 128 Protocol No. PoArvi/PhIII_2017 Sponsor: NPO Petrovax Pharm LLC, Russia Version: 2.0 of 30/05/2018 Study population and the Patients with a clinically confirmed diagnosis of ARVI (ICD-10 code: number of enrolled patients: J00, J02, J04, J06) will be randomized and assigned to one of two groups at the ratio 1:1: Group 1 - patients will receive the study product as part of complex therapy; Group 2 - patients will receive placebo as part of complex therapy. Calculation of the sample size is based on the following Formula: 7 о 2 SD1 n=(Za+Z ) - —у where, Za and Z|3 are critical values of the normal distribution corresponding to the established error levels a and P (a- and P-errors are 0.05 and 0.2, respectively), SD - a standard deviation [25 - 28]. As a result of calculation based on the above values (Za=1.645, Zp=0.842, SD=0.2 day, 5=-0.52 day, цо=2.6 days, and цр=3.2 days), the sampling size was obtained that ensures a statistical study power of at least 80%, equal to 78 patients in each group (156 subjects in total). Taking into account the possible dropout of 10% of patients, the sample size will be extended to 86 subjects in each group (172 subjects in total). Calculations were performed using the R v Statistics package. 3.4.3. Taking into account the possible dropout of patients at screening, it is planned to screen210 patients in the study, of whom172 will be randomized. Study sites Medical Technologies Limited Liability Company. Address: 6, Nevzorovoy st., Saint Petersburg, 192148. State Budgetary Institution of Public Health of Yaroslavl region "Regional Children's Clinical Hospital". Address: 27, Tutaevskoe chaussee, Yaroslavl, 150042. Municipal Children’s Clinic No. 4. Address: 122/1, Dneprovsky per., Rostov-on-Don, 344065. Kurator, Limited Liability Company. Address: 125, Krasnoputilovskaya st., building A, room 13N, St. Petersburg, 196240. St. Petersburg State Budgetary Institution of Public Health "Children's Municipal Hospital No. 22". Address: 1, Zavodskoy prosp., Kolpino, Saint Petersburg, 196657. State Budgetary Institution of Public Health of Yaroslavl region "Municipal Children's Clinical Hospital No. 5". Address: 10 Soviet Army St., Perm, Russia, 614066. ArsVite Northwest Limited Liability Company. Address: 7, Constitution Square, lit. A., office 413, Saint Petersburg, 196191. Confidential Page 4 of 128 Protocol No. PoArvi/PhIII_2017 Sponsor: NPO Petrovax Pharm LLC, Russia Version: 2.0 of 30/05/2018 MDP-Medical Group Limited Liability Company. Address: 7, Constitution Square, lit. A., office 413, Saint Petersburg, 196247. SHCI Yaroslavl Clinical Hospital No. 8. Address: 39, Suzdalskoe chaussee, Yaroslavl, 150030. KOROLEV MEDICINA LLC. Address: 8/1, Kalinina st., room 63, Naro-Fominsk, Moscow Oblast, 143300. Business place: 5, Oktyabrsky Boulevard, nonresidential premise No. 01, rooms 2-10, 14, 15, Korolev Moscow Oblast, 141077 ; Nebbiolo LLC. Address: 23, Ostrovsky Lane, Tomsk, 634009. FSBI Research Institute of Influenza at the Ministry of Health of the Russian Federation. Address: 15/17 prof. Popov st., Saint Petersburg, 197376. MedEstheticCenter Laboratory LLC. Address: 26, Karavaevskaya st., block 1, lit. A, Saint Petersburg, 192177 . Clinical Laboratory Local laboratories of the clinical centers that are declared to conduct this study will be used to perform laboratory tests. Eligibility criteria Inclusion criteria: Patients of both sexes at the age of 1 to 12 years inclusive. Diagnosis of ARVI [ICD-10 code: J00 - Acute nasopharyngitis (runny nose), J02 - Acute pharyngitis, J02.9 - Unspecified acute pharyngitis, Acute laryngitis and tracheitis - J04, J04.0 - Acute laryngitis, J04.1 - Acute tracheitis, J04.2 - Acute laryngitis, Acute upper respiratory tract infections of multiple and unspecified localization - J06, J06.0 - Acute laryngopharyngitis, J06.9 - Acute upper respiratory tract infection, unspecified] confirmed by physician's examination: axillary temperature > 37.0 °C (measured at the moment of physical examination) and Symptom Assessment Scale total score > 5 points, not less than 3 of which should be related to ENT-organs and upper respiratory tract affection (accord.
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