NCT05269290

Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza, Human
• Acute Respiratory Infection
• Common Cold

Interventions

Type	Name	Description
DRUG	Ingavirin®, syrup, 30 mg/5 ml	A dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy.
DRUG	Placebo	Placebo will be administered once a day on top of standard therapy.

Timeline

• Start date: 2021-09-23
• Primary completion: 2022-04-29
• Completion: 2022-07-15
• First posted: 2022-03-07
• Last updated: 2023-07-27

Locations

8 sites across 1 country: Russia