[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-respiratory-viral-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-respiratory-viral-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100571103","phase-3-clinical-trial-of-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-arvi-in-children-aged-3-12-years-100571103",false,"NCT06715891","Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years","A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years","Inclusion Criteria:\n\n1. Children of either gender aged 3 to12 years .\n2. Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal\u002Fthroat\u002Fchest symptoms ≥2 points (ARVI Symptom Severity Score).\n3. 24 hours from the ARVI onset .\n4. Availability of a patient information sheet and an informed consent form for the patient's parents\u002Fadopters for patient participation in the clinical trial signed by one parent\u002Fadopter of the patient.\n\nExclusion Criteria:\n\n1. Clinical symptoms of severe influenza\u002FARVI requiring hospitalization.\n2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease.\n3. Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).\n4. Patients who require administration of antiviral medications that are prohibited for use in this trial.\n5. History or prior diagnosis of primary and secondary immunodeficiency.\n6. History\u002Fsuspicion of oncology of any localization (except for benign neoplasms).\n7. Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.\n8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n9. Allergy\u002Fhypersensitivity to any component of the medicines used in the treatment.\n10. Use of medications listed under \"Prohibited Concomitant Treatment\" within 2 weeks prior to inclusion in the trial.\n11. Patients whose parents\u002Fadopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.\n12. History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents\u002Fadopters of the patient.\n13. Participation in other clinical trials within 3 months prior to inclusion in this trial.\n14. A patient's parent\u002Fadopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.\n15. The patient's parent\u002Fadopter is employed by OOO \"NPF \"MATERIA MEDICA HOLDING\", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.","ALL","3 Years","12 Years",{"count":20,"type":21},374,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.",[27],"Acute Respiratory Viral Infection",[29,30,31],"respiratory viral infection","children","aged 3-12 years","RECRUITING","2026-03-11",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2024-11-11",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Materia Medica Holding","INDUSTRY",35,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":69},"100625311","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-the-ingavirin-forte-capsules-valenta-pharm-jsc-at-different-doses-in-subjects-with-influenza-and-other-acute-respiratory-viral-infections-100625311","NCT07420985","Study to Evaluate the Efficacy, Safety, and Tolerability of the Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.","A Multicenter, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of the Investigational Product Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.","Inclusion Criteria:\n\n1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;\n3. Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);\n4. Presence of clinically significant signs of influenza or acute respiratory viral infections at screening:\n\n   * Body temperature \\>38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;\n   * Presence of at least two of the following symptoms of influenza or other acute respiratory viral infections (cough, rhinorrhea, sore throat, or a throat irritation) each rated non less than 6 points on a numeric rating scale (NRS);\n   * Presence of at least one of the following systemic manifestations of influenza or other acute respiratory viral infections (headache, myalgia, or general weakness) rated non less than 6 points on a numeric rating scale (NRS).\n5. Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours;\n6. No clinical indications for hospitalization at the time of study enrollment;\n7. Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion. The follwing subjects are eligible for inclusion in the study:\n\n   * Females of childbearing potential must have a negative pregnancy test and use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives, contraceptive subdermal implant, intrauterine hormonal system, intrauterine device. Females not of childbearing potential (i.e., with a history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, comfirmed infertility, or ≥ 2 of menopause) are also eligible for participation;\n   * Males with reptoductive potential must use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives. Males with infertility or a history of vasectomy are also eligible for participation;\n\nExclusion Criteria:\n\n1. Clinically significant allergic history;\n2. Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and\u002For to any excipient contaned in the investigational medicinal product or comparator;\n3. Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and\u002For to any excipient contaned in the investigational medicinal product or comparator;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Clinical suspicion of pneumonia of any etiology, or other bacterial infection (e.g. sinusitis, otitis media, urinary tract infection, meningitis, sepsis) requiring initiation for antibacterial therapy;\n6. Nasal obstruction due to structural pathology, such as sequelae of nasal trauma, nasal polyps, septal deviation, or other organic causes;\n7. History of vasomotor rhinitis;\n8. Administration of antibiotics, antiviral (including Ingavirin), or immunomodulatory agents within 48 hours prior to study, and\u002For anticipated need for any of these agents during the study;\n9. Vaccination within 90 days prior to study enrollment;\n10. Uncontrolled diabetes mellitus;\n11. Obesity, class II or III (body mass index ≥35 kg\u002Fm²);\n12. Pregnancy or lactation;\n13. Positive test for SARS-CoV-2 at screening;\n14. History of autoimmune diseases;\n15. Current or past HIV, syphilis, hepatitis B and\u002For C, or tuberculosis;\n16. Known or suspected history of alcohol, psychotropic drug, or substance abuse or dependence;\n17. History of chronic respiratory disease, including but not limited to: chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, diffuse panbronchiolitis, pulmonary emphysema, or pulmonary fibrosis;\n18. Chronic heart failure, New York Heart Association (NYHA) functional class III or IV;\n19. Current or past psychiatric disoder;\n20. Any clinically significant cardiovascular, renal, hepatic, gastrointestinal , endocrine, or neurological disoder, including severe uncompensated chronic conditions (e.g., chronic kidney disease, chronic liver disease) or acute illness, or any other medical or psychiatric condition that, in investigator's opinion, could pose a safety risk to the subject if they participate in the study;\n21. Subject's refusal to use an adequate method of contraception or to practice continuous sexual abstinence throughout the study and for 30 days after study completion;\n22. Participation in another clinical trial within 3 months prior to screening;\n23. Other conditions which, in the judgment of the investigator, could compromise the subject's participation in the study or pose an undue risk.\n\nExclusion Criteria:\n\n1. Subject's decision to withdraw from the study (withdrawal of informed consent);\n2. Investigator's decision to discontinue the subject from the study in the subject's best interest;\n3. Investigator-determined need for a concomitant therapy explicitly prohibited by the protocol of clinical study;\n4. Subject's use of a therapy prohibited by the protocol;\n5. Positive urine test for beta-human chorionic gonadotropin (β-hCG) in females of childbearing potential;\n6. Lack of adequate cooperation by the subject with the investigator during the study;\n7. Emergence during the study of conditions or events that jeopardize subject safety (e.g., hypersensitivity reactions, serious adverse events \\[SAEs\\]) or, in the investigator's medical judgment, worsen the subject's prognosis or preclude further participation in the clinical study;\n8. Incorrect inclusion of a subject who does not meet the protocol-specified inclusion and\u002For exclusion criteria;\n9. Major deviation from the treatment regimen, defined as:\n\n   * Missing two or more consecutive doses of the investigational medicinal product (IMP) or comparator;\n   * Total intake of fewer than 80% or more than 120% of the planned total number of capsules (full course includes 10 capsules);\n10. Confirmed diagnosis of COVID-19;\n11. Occurrence during the study of any other condition that precludes adherence to the protocol;\n12. Subject's death.","18 Years","65 Years",{"count":55,"type":21},300,[57],"PHASE2","The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).",[60,27],"Influenza","2026-02-11",{"date":63,"type":36},"2026-02-19",{"date":65,"type":36},"2025-10-24",{"date":40,"type":21},{"name":68,"class":43},"Valenta Pharm JSC",11]