protocolSection identificationModule nctId: NCT06379542, orgStudyIdInfo id: XC8-03-05-2023, briefTitle: Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo., conditionsModule conditions: Acute Respiratory Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: XC8, interventions name: Placebo, outcomesModule primaryOutcomes measure: Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1, secondaryOutcomes measure: Number of cough attacks by day 5, day 8, day 11 and day 15, secondaryOutcomes measure: Time (days) from visit 1 until clinical cough cure is achieved, secondaryOutcomes measure: Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1, secondaryOutcomes measure: Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1, secondaryOutcomes measure: Percentage of patients needed acetylcysteine, secondaryOutcomes measure: Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14, secondaryOutcomes measure: Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5, secondaryOutcomes measure: Number of adverse events (AEs), secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Percentage of patients with AEs, secondaryOutcomes measure: Percentage of patients who interrupted treatment, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: City Pediatric Outpatient Clinic number 5, status: RECRUITING, city: Perm, zip: 614066, country: Russian Federation, contacts name: Olga Perminova, MD, PhD, role: CONTACT, phone: +7 (912) 882 0549, email: perminova20062006@yandex.ru, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Professors' Clinic LLC., status: RECRUITING, city: Perm, zip: 614070, country: Russian Federation, contacts name: Svetlana Teplykh, MD, PhD, role: CONTACT, phone: +7 (919) 498 2931, email: profkliniki@mail.ru, geoPoint lat: 58.01046, lon: 56.25017, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44", status: RECRUITING, city: Saint Petersburg, zip: 192071, country: Russian Federation, contacts name: Olga V Trusova, MD,PhD, role: CONTACT, phone: +7 (812) 417-40-02, email: o-tru@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: ArsVite North-West, LLC, status: RECRUITING, city: Saint Petersburg, zip: 194223, country: Russian Federation, contacts name: Svetlana G Lazareva, MD, role: CONTACT, phone: +7-812-335-29-58, email: alexlaz58@rambler.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: PiterKlinika LLC, status: RECRUITING, city: Saint Petersburg, zip: 196158, country: Russian Federation, contacts name: Tatiana Pak, MD,PhD, role: CONTACT, phone: +7 (981) 851 8150, email: pte@list.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35", status: RECRUITING, city: Saint Petersburg, zip: 196191, country: Russian Federation, contacts name: Tatiana I Antonova, MD, PhD, role: CONTACT, phone: +7-812-246-46-45, email: antian@bk.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False