NCT05544916

A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections

A Double-blind, Randomized, Placebo-controlled, Comparative, Multicenter Phase III Clinical Trial to Study the Clinical Efficacy and Safety of XC221, Tablets, 100 mg in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study was to evaluate the effectiveness of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other acute respiratory viral infections (ARIs). An additional purpose of the study was to evaluate the safety of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other ARIs.

Conditions

• Influenza
• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	XC221	200 mg/day, for 5 days
DRUG	Placebo	2 tablets/day, for 5 days

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-02-01
• Completion: 2023-05-04
• First posted: 2022-09-19
• Last updated: 2023-10-10

Locations

13 sites across 1 country: Russia