NCT03191097

Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.

Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Children 7-12 y.o.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in 7-12 years old patients.

Conditions

• Influenza, Human
• Acute Respiratory Infection
• Viral Infection
• Common Cold

Interventions

Type	Name	Description
DRUG	Ingavirin	Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.
DRUG	Placebo oral capsule	Placebo, capsules daily for 5 days.

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2017-06-19
• Last updated: 2017-06-19

Locations

11 sites across 1 country: Russia