A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Gilead Sciences
- Enrollment
- 4
- Locations
- 49
- Primary Endpoint
- Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities by Day 28
Overview
Brief Summary
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve.
The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
Detailed Description
Pediatric participants will be enrolled as follows:
- Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg
- Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants assigned male or female at birth, from birth to \< 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
- •Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg
- •Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
- •RSV infection diagnosis ≤ 3 days prior to randomization.
- •Negative test for influenza A/B, and SARS-CoV-2 infection ≤ 7 days prior to randomization.
- •Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
- •Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Exclusion Criteria
- •Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
- •Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- •Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
- •History of asthma or recurrent wheezing.
- •Neuromuscular disease that affects swallowing.
- •Cystic fibrosis.
- •Participants who are immunocompromised.
- •Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
- •Abnormal renal function.
- •Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
Arms & Interventions
Obeldesivir Placebo
Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment.
Intervention: Obeldesivir Placebo (Drug)
Obeldesivir
Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.
Intervention: Obeldesivir (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities by Day 28
Time Frame: First dose up to 28 days
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 28
Time Frame: First dose up to 28 days
Time to Alleviation of Targeted RSV Symptoms by Day 28
Time Frame: First dose up to 28 days
Secondary Outcomes
- Pharmacokinetic (PK) parameter AUCtau of ODV metabolite, GS-441524(Day 1 to Day 5)
- PK parameter Cmax of ODV metabolite, GS-441524(Day 1 to Day 5)
- PK parameter Ctrough of ODV metabolite, GS-441524(Day 1 to Day 5)
- Change From Baseline in RSV Nasal Swab Viral Load at Day 5(Baseline, Day 5)
- Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28(First dose up to 28 days)
- Time to Resolution of Targeted RSV Symptoms by Day 28(First dose up to 28days)
- Assessment of Palatability and Acceptability Scores of Age-specific Formulation as Assessed by Caregiver at Days 1 and 5(Day 1 to Day 5)