drugset / Trial / NCT05030324

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

NCT05030324 ↗

Phase 2 Completed 255 enrolled Valenta Pharm JSC
RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter, randomized, double-blind, placebo controlled comparative study to evaluate the safety, tolerability and efficacy of XC221 used at 100 mg daily and at 200 mg daily in patients with uncomplicated influenza or other acute viral upper respiratory infections (URIs) for 5 days of treatment. The primary objective of the study is to evaluate the efficacy of ХС221 at 100 mg and at 200 mg in comparison with placebo regarding its effect on the severity and duration of influenza symptoms and symptoms of other viral URIs (fever and other major signs and symptoms). The secondary objective of the study is to evaluate the safety of ХС221 at 100 mg and at 200 mg in comparison with placebo in the treatment of influenza ad other viral URIs.

Timeline

Start
2021-10-01
Primary completion
2022-05-04
Completion
2022-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject XC221 Unknown 100 mg Oral
Subject XC221 Unknown 200 mg Oral

Indications