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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Influenza
• Acute Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	Ingavirin Forte, 90 mg + 5 mg, Capsules	90 mg + 5 mg, 1 capsule twice a day, for 5 days
DRUG	Ingavirin Forte, 90 mg + 10 mg, Capsules	90 mg + 10 mg, 1 capsule twice a day, for 5 days
DRUG	Ingavirin Forte, 90 mg + 20 mg, Capsules	90 mg + 20 mg,1 capsule twice a day, for 5 days
DRUG	Ingavirin, 90 mg, Capsules	90 mg, 1 capsule twice a day, for 5 days
DRUG	Placebo	1 capsule twice a day, for 5 days

Timeline

• Start date: 2025-10-24
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

11 sites across 1 country: Russia