A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

Phase 3 Terminated 553 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

Timeline

Start: 2018-01-21
Primary completion: 2020-05-28
Completion: 2020-08-24

Outcome

Met primary endpoint

Stopped: “Based on interim Analysis outcome being futile for FLZ3001; decision was taken to stop (early terminate) both FLZ3001/3002. There was no safety concern.”

registry analysis (superiority test); Pimodivir + SOC vs Placebo + SOC; p = 0.0216; Gehan-Wilcoxon test NCT03381196 ↗

Publications

Leopold L, Vingerhoets J, Deleu S, Nalpas C, Weber K, van Dromme I, Lowson D, Michiels B, van Duijnhoven W. Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection. J Infect Dis. 2025 Feb 4;231(1):e132-e143. doi: 10.1093/infdis/jiae408.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimodivir	Small molecule	600 mg	Oral