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Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection

TerminatedPhase 2

Sponsor: Gilead Sciences

Conditions: RSV Infection

Interventions: Obeldesivir, Obeldesivir Placebo

Countries: United States, Japan

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.

Eligibility overview

Sex: ALL

Age: — to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 ≥ 3 kg to \< 40 kg (Part A) and ≥ 1.5 kg to \< 3 kg (Part B)
* 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 severe acute respiratory syndrome coronavirus 2 (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.
* Not expected to survive the current RSV-related illness.
* 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.

Locations (56)

Birmingham, Alabama, United States
Oneonta, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Lynwood, California, United States
Modesto, California, United States
San Diego, California, United States
Santa Maria, California, United States
Washington D.C., District of Columbia, United States
Doral, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Union City, Georgia, United States
Idaho Falls, Idaho, United States
Sioux City, Iowa, United States
Lafayette, Louisiana, United States
Great Falls, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Syracuse, New York, United States
Chickasha, Oklahoma, United States
Yukon, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Burleson, Texas, United States
DeSoto, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
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