Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
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ClinicalTrials.gov Identifier: NCT05269290 |
Recruitment Status :
Recruiting
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | January 28, 2022 | ||||
First Posted Date ICMJE | March 7, 2022 | ||||
Last Update Posted Date | March 7, 2022 | ||||
Actual Study Start Date ICMJE | September 23, 2021 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time of symptoms/events resolution [ Time Frame: From Day 1 up to Day 13-14 (visit 4) ] 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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections | ||||
Official Title ICMJE | A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children Aged 6 Months to 2 Years With Influenza and Other Acute Respiratory Viral Infections Against Standard Therapy | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
284 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 2 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Russian Federation | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05269290 | ||||
Other Study ID Numbers ICMJE | ING-03-04-2020 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Valenta Pharm JSC | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Valenta Pharm JSC | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Valenta Pharm JSC | ||||
Verification Date | January 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |