Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory, Syncytial, Virus, RSV
Brief summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
Interventions
DRUGGS-5806
Single dose, oral liquid, .5 mL/kg
DRUGPlacebo
Single dose, oral liquid, .5 mL/kg
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 10 days from subject randomization to study drug | Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics effects of GS-5806 | 10 days from subject randomization to study drug | Evaluation of GS-5806 on viral load related and symptom related endpoints. |
Countries
Australia
Outcome results
None listed