Trials / Completed
CompletedNCT02135614
Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 189 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Presatovir | Presatovir 200 mg (4 x 50 mg tablets) administered orally |
| DRUG | Presatovir placebo | Presatovir placebo tablets administered orally |
Timeline
- Start date
- 2014-06-09
- Primary completion
- 2017-03-27
- Completion
- 2017-04-12
- First posted
- 2014-05-12
- Last updated
- 2018-09-24
- Results posted
- 2018-05-11
Locations
43 sites across 11 countries: United States, Australia, Belgium, France, Israel, Italy, Netherlands, New Zealand, Poland, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02135614. Inclusion in this directory is not an endorsement.