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