NCT05095545

Dose Range Study to Evaluate the Efficacy and Safety of AV5080 in Patients With Influenza

Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Efficacy and Safety of the AV5080 Drug in Patients With Influenza

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Assessment of the effect reached with the different doses of AV5080 on the duration and severity of influenza symptoms based on the incidence of their resolution within 96 hours from study treatment initiation compared to Placebo. The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.

Detailed description

The study was a multi-center, double-blind, randomized, parallel- group clinical study to assess the efficacy and safety of different AV5080 doses as compared to placebo in patients with influenza during the 5-day treatment period. The study included only patients with influenza of mild and moderate severity, without complications, both outpatients and those hospitalized for epidemiological reasons. The study included three periods for each patient: Screening, randomization, and study treatment, follow up period.

Conditions

• Influenza

Interventions

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

Timeline

• Start date: 2017-11-13
• Primary completion: 2019-08-07
• Completion: 2019-08-30
• First posted: 2021-10-27
• Last updated: 2021-10-27

Locations

10 sites across 1 country: Russia