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The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30 mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from 6 months to 2 years compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingavirin®, syrup, 30 mg/5 ml | Experimental | Ingavirin®, syrup, 30 mg/5 ml will be administered on top of standard therapy |
|
| Placebo | Placebo Comparator | Placebo will be administered on top of standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingavirin®, syrup, 30 mg/5 ml | Drug | A dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of symptoms/events resolution | Time, in hours, from the first administration of the drug until all of the following symptoms/events have resolved (if each symptom/event has been achieved for at least 24 hours): Fever; Cough and/or runny nose/nasal congestion; Child's return to normal daytime activity and normal nighttime sleep (as assessed by the parent/adopter). | From Day 1 up to Day 13-14 (visit 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fever relief | Number of hours elapsed from the first administration of the medication to the time of persistent normalization of the temperature, i.e., the moment when the body temperature is < 37.5 °C during the day without the use of antipyretic medication | From Day 1 up to Day 13-14 (visit 4) |
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Inclusion Criteria:
Exclusion Criteria:
12. Lactose intolerance, lactase deficiency or glucose-galactose malabsorption. 13. Taking antibiotics, antivirals, or immunomodulatory drugs within < 48 h prior to the study and/or plans to use these groups of drugs (other than the study drug) during the study; 14. Use of systemic, inhaled, or nasal glucocorticosteroids within 30 days prior to the study and/or plans to use glucocorticosteroids (except topical cutaneous agents) during the study; 15. Failure to withdraw for the duration of the study other medications that may affect the outcome of this study, such as antiviral medications, or medications that are incompatible with the study therapy (see "prohibited concomitant therapies"); 16. Patient's participation in any other clinical trial within 90 days prior to inclusion in the study; 17. Any cardiovascular, renal, hepatic, gastrointestinal (GI), endocrine, or nervous system disease, severe decompensated chronic or acute disease, or any other condition/disease that, in the opinion of the investigating physician, would make it unsafe for the patient to participate in the study; 18. Having any vaccinations administered to the patient within 14 days prior to inclusion in the study; 19. Diabetes mellitus; 20. Clinical suspicion of pneumonia or other bacterial infections (including sinusitis, otitis media, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibacterial drugs; 21. Patients who have had surgery within 30 days prior to the Screening Visit and patients who are scheduled to have surgery, including diagnostic procedures, or a hospital stay during the study; 22. Suspicion of hemophagocytic syndrome; 23. Increased seizure activity in the history; 24. The presence of cancer, HIV infection, tuberculosis, including in the anamnesis; 25. Suspected low compliance of the parent/adopter with the child's treatment and recording of required parameters in the Patient Diary, or inability to perform these procedures and comply with restrictions according to the study protocol (e.g., due to mental illness).
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Research and Clinical Center of Physical and Chemical Medicine of the Federal Medical and Biological Agency | Odintsovo | Moscow Oblast | 1430010 | Russia |
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| Placebo | Drug | Placebo will be administered once a day on top of standard therapy. |
|
| Time to cough relief |
Number of hours from the first dose to the time the coughing cough has gone away, i.e. the parent/adoptive parent rates the symptom as 0-1 during the day and records this in the patient's diary |
| From Day 1 up to Day 13-14 (visit 4) |
| Time to cough/nasal congestion relief | Number of hours from first medication administration to cough/congestion cessation, i.e., when parent/adopter rates severity of this symptom during the day at 0-1 point and records this in patient diary | From Day 1 up to Day 13-14 (visit 4) |
| Frequency of complications of acute viral infection and influenza | Acute otitis media, viral and bacterial pneumonia, exacerbation of chronic conditions such as bronchial asthma and urinary tract infections), toxemia [septic-like syndrome], acute stenotic laryngotracheitis | From Day 1 up to Day 13-14 (visit 4) |
| Frequency of patients with PCR-confirmed viral infection | PCR-confirmed acute respiratory infections/flu by visits 1, 2, 3 | Day 1, Day 3-4 (visit 2), Day 6-7 (visit 3) |
| Need for paracetamol or ibuprofen | Daily dose on study days 1-7 | Days 1-7 |
| Safety - Number of adverse events (AEs) | Total number of AEs stratified by severity and frequency | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Adverse reactions | Frequency of adverse reactions | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Serious adverse events (SAEs) | Frequency of serious adverse events (SAEs) associated with study drug/placebo use | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Percentage of patients with AEs | Percentage of patients with at least one AE | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Percentage of patients who interrupted treatment | Percentage of patients who interrupted treatment due to AE | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Frequency of complications | Frequency of complications | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Frequency of worsening | Frequency of worsening of the disease course | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| Safety - Frequency of hospitalization | Frequency of need for hospitalization | From Day 1 up to Day 13-14 (visit 4) or up to early termination visit within time frame of the study |
| City Pediatric Outpatient Clinic number 5 | Perm | 614066 | Russia |
| Professors' Clinic LLC. | Perm | 614070 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44" | Saint Petersburg | 191144 | Russia |
| City Polyclinic No. 45 of Nevsky District | Saint Petersburg | 193312 | Russia |
| PiterKlinika LLC | Saint Petersburg | 196158 | Russia |
| Uromed LLC | Smolensk | 214031 | Russia |
| Bashkir State Medical University | Ufa | 450008 | Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
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| ID | Term |
|---|---|
| C539419 | pentanedioic acid imidazolyl ethanamide |
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