Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

Gilead Sciences

Overview

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Respiratory Syncytial Virus Infections

Interventions

GS-5806DRUG

Single dose, oral liquid, .5 mL/kg

PlaceboDRUG

Single dose, oral liquid, .5 mL/kg

Eligibility

Sex: ALLMin age: 1 HourMax age: 24 Months

Medical Language ↔ Plain English

Inclusion Criteria: * \<24 months of age * Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening Exclusion Criteria: * Chronic or congenital heart disease * Required ventilation or admission to any pediatric Intensive Care Unit * Inadequate organ function

Locations (9)

Geelong Hospital

Geelong, Victoria, Australia

Monash Medical Center

Clayton, Australia

Queensland Children's Medical Research Unit

Herston, Australia

Royal Hobart Hospital

Hobart, Australia

Outcomes

Primary Outcomes

Safety and tolerability

Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.

Time frame: 10 days from subject randomization to study drug

Secondary Outcomes

Pharmacokinetics effects of GS-5806

Evaluation of GS-5806 on viral load related and symptom related endpoints.

Time frame: 10 days from subject randomization to study drug

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.