NCT05093998

Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza

Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza.

Detailed description

This study is an international, multicenter, double-blind, randomized, placebo-controlled, phase III clinical trial in parallel groups evaluating the efficacy and safety of AV5080 in patients with uncomplicated influenza. Only patients with mild to moderate influenza, without complications, will be included in the study. Taking into account the seasonality of the pathology and the low percentage of influenza in the general structure of ARVI incidence, for the successful inclusion of all patients in the study during two epidemiological seasons. The study will enroll 700 patients aged 18 to 65 years with a confirmed clinical diagnosis of influenza to treatment (AV5080) and placebo cohorts (1:1).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	AV5080	oral hard gelatin capsules
OTHER	Placebo	Hard gelatin capsules with a white body

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-07-15
• Completion: 2023-07-31
• First posted: 2021-10-26
• Last updated: 2021-10-26

Locations

6 sites across 1 country: Russia