CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 189 enrolled
Drug / intervention
Presatovir +1 moredrug
Likely dose
Presatovir 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02135614
NCT02135614Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

Gilead Sciences·interventional·Posted May 12, 2014·Updated Sep 24, 2018

In Brief

A Phase 2 clinical trial evaluating Presatovir and Presatovir placebo for Respiratory Syncytial Virus Infection. Completed, enrolled 189 participants across 43 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infection
CountriesAustralia, Belgium, France, Israel, Italy, Netherlands, New Zealand, Poland, South Korea, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 12, 2014
Enrollment StartJun 9, 2014
Primary CompletionMar 27, 2017
Study CompletionApr 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.1 years ago

Interventions

Presatovirdrug

Presatovir 200 mg (4 x 50 mg tablets) administered orally

Presatovir placebodrug

Presatovir placebo tablets administered orally