Set-up of an upcoming clinicl trial has been posted with the primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
Coordinating closely with the U.S. Food and Drug Administration, Gilead has designed and will soon begin enrollment of an open-label, single-arm Phase 2/3 clinical trial that will evaluate the safety, tolerability, pharmacokinetics and efficacy of remdesivir in treating approximately 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents. This important trial will be conducted at more than 30 sites in the United States and Europe.
The pediatric study is the latest demonstration of Gilead’s commitment to continued research on remdesivir that may help address emerging patient needs, with the goal of improving outcomes for people with the disease in communities around the world.”
This study is estimated to start in the coming weeks and complete by the end of this year.