Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

Summary

The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

Timeline

Start

2014-06-09

Primary completion

2017-03-27

Completion

2017-04-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Presatovir vs Placebo; p = 0.46; Treatment difference 0.12 (95% CI -0.20 to 0.43) NCT02135614 ↗

Drugs

Indications