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

NCT02135614 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2018-09-24

Study results available
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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

  • Respiratory Syncytial Virus Infection

Interventions

DRUG

Presatovir

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

DRUG

Presatovir placebo

Presatovir placebo tablets administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-09
Primary Completion
2017-03-27
Completion
2017-04-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135614 on ClinicalTrials.gov