protocolSection identificationModule nctId: NCT06315400, orgStudyIdInfo id: ING-07-2023, briefTitle: Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo., conditionsModule conditions: Influenza, Human, conditions: Acute Respiratory Infection, conditions: Common Cold, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Ingavirin®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of patients with normalization of body temperature at Visit 3 (Day 3), secondaryOutcomes measure: Timeframe for normalization of body temperature from the start of treatment, measured in hours, secondaryOutcomes measure: Time of cough disappearance from the moment of treatment initiation, secondaryOutcomes measure: Percentage of patients with absence of catarrhal syndrome, secondaryOutcomes measure: Percentage of patients with absence of intoxication syndrome, secondaryOutcomes measure: Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy, secondaryOutcomes measure: Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration, secondaryOutcomes measure: Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration, secondaryOutcomes measure: Assessment of vital signs: blood pressure, secondaryOutcomes measure: Assessment of vital signs: heart rate, secondaryOutcomes measure: Assessment of vital signs: respiratory rate, secondaryOutcomes measure: Assessment of vital signs: body temperature, secondaryOutcomes measure: Evaluation of concomitant therapy, secondaryOutcomes measure: Laboratory evaluation: leukocyte formula, secondaryOutcomes measure: Laboratory evaluation: hemoglobin, secondaryOutcomes measure: Laboratory evaluation: leukocyte count, secondaryOutcomes measure: Laboratory evaluation: platelet count, secondaryOutcomes measure: Laboratory evaluation: red blood cell count, secondaryOutcomes measure: Laboratory evaluation: hematocrit, secondaryOutcomes measure: Laboratory evaluation: erythrocyte sedimentation rate, secondaryOutcomes measure: Laboratory evaluation: blood glucose, secondaryOutcomes measure: Laboratory evaluation: total protein, secondaryOutcomes measure: Laboratory evaluation: total bilirubin, secondaryOutcomes measure: Laboratory evaluation: AST, secondaryOutcomes measure: Laboratory evaluation: ALT, secondaryOutcomes measure: Laboratory evaluation: creatinine, secondaryOutcomes measure: Laboratory evaluation: urea, secondaryOutcomes measure: Laboratory evaluation: triglycerides, secondaryOutcomes measure: Laboratory evaluation: urinalysis, secondaryOutcomes measure: Frequency of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Percentage of patients who discontinued study due to AE/SAE, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Rostov-na-Donu, country: Russian Federation, contacts name: Tatiana V Zolotova, Prof., role: CONTACT, phone: +7-928-1049101, email: tvzolotova1953@yandex.ru, geoPoint lat: 47.23135, lon: 39.72328, locations facility: GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Tomsk, country: Russian Federation, contacts name: Yulia G Samoilova, MD, PhD, role: CONTACT, phone: +7-3822530127, email: samoilova_y@inbox.ru, geoPoint lat: 56.49771, lon: 84.97437, locations facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Ivan G Sitnikov, Prof., role: CONTACT, phone: +7-4852-736769, email: sitnikov@ysmu.ru, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False