Clinical trial NCT06784973: Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: RSV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 130
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Key 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.

Key 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.
* Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
* Participant whose mother received RSV vaccination during pregnancy and who is \< 1 year old prior to randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 28
timeFrame: First dose up to 28 days
measure: Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities by Day 28
timeFrame: First dose up to 28 days
measure: Time to Alleviation of Targeted RSV Symptoms by Day 28
timeFrame: First dose up to 28 days
Secondary outcomes:
measure: Pharmacokinetic (PK) parameter AUCtau of ODV metabolite, GS-441524
timeFrame: Day 1 to Day 5
measure: PK parameter Cmax of ODV metabolite, GS-441524
timeFrame: Day 1 to Day 5
measure: PK parameter Ctrough of ODV metabolite, GS-441524
timeFrame: Day 1 to Day 5
measure: Change From Baseline in RSV Nasal Swab Viral Load at Day 5
timeFrame: Baseline, Day 5
measure: Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28
timeFrame: First dose up to 28 days
measure: Time to Resolution of Targeted RSV Symptoms by Day 28
timeFrame: First dose up to 28days
measure: Assessment of Palatability and Acceptability Scores of Age-specific Formulation as Assessed by Caregiver at Days 1 and 5
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Oneonta
country: United States
facility: Midway Medical Clinic
state: Alabama
city: Phoenix
country: United States
facility: Cohen Children's Medical Center Pharmacy New Pavillion
state: Arizona
city: Phoenix
country: United States
facility: Velocity Clinical Research, Phoenix
state: Arizona
city: Los Angeles
country: United States
facility: UCLA (Outpatient Clinic)
state: California
city: Lynwood
country: United States
facility: Alliance Research Institute
state: California
city: Modesto
country: United States
facility: Paradigm Clinical Research
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research Centers, LLC
state: California
city: Santa Maria
country: United States
facility: FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
state: California
city: Washington
country: United States
facility: Velocity Clinical Research, Washington DC
state: District of Columbia
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Orlando
country: United States
facility: Nona Pediatric Center
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Macon
country: United States
facility: Velocity Clinical Research, Primary Pediatrics, Macon
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette
state: Louisiana
city: Great Falls
country: United States
facility: Boeson Research
state: Montana
city: Kalispell
country: United States
facility: Boeson Research
state: Montana
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Norfolk
country: United States
facility: Velocity Clinical Research - Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Chickasha
country: United States
facility: Epic Medical Research -Oklahoma
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: PAS Research
state: Pennsylvania
city: Burleson
country: United States
facility: Helios Clinical Research
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - DeSoto
state: Texas
city: Edinburg
country: United States
facility: PAS Research
state: Texas
city: Houston
country: United States
facility: Helios Clinical Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Sunrise Pediatrics
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc.
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research
state: Texas
city: Richmond
country: United States
facility: Pediatric Center
state: Texas
city: San Antonio
country: United States
facility: Central Texas Medical Research, LLC
state: Texas
city: Tomball
country: United States
facility: North Houston Internal Medicine and Pediatric Clinic
state: Texas
city: Kaysville
country: United States
facility: Tanner Clinic
state: Utah
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Provo
country: United States
facility: Boeson Research PVU
state: Utah
city: Akashi
country: Japan
facility: Yoshimura Child Clinic
city: Fkitakyushu
country: Japan
facility: Japan Community Healthcare Organization Kyushu Hospital
city: Fukuoka
country: Japan
facility: Uchida child clinic
city: Fukuoka
country: Japan
facility: Shindo Children's Clinic
city: Fukuoka
country: Japan
facility: SEKI Children's CLINIC
city: Ibaraki
country: Japan
facility: Ryuseidai Children's Clinic
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
city: Kanagawa
country: Japan
facility: Abe Child Clinic
city: Kasukabe
country: Japan
facility: Okada Kodomonomori Clinic
city: Kobe
country: Japan
facility: Yutaka Children Clinic
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Nagoya
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
city: Nerima-ku
country: Japan
facility: Shimamura Memorial Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Welfare Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: