Gilead to Test Antiviral Drug Remdesivir in COVID-19 Pediatric Patients

(Foster City, CA, USA) is further advancing the development of its investigational antiviral remdesivir for the treatment of COVID-19 by conducting Phase 2/3 clinical trial of the drug in pediatric patients.

While the novel coronavirus appears to disproportionally affect adults, especially the elderly and those with underlying health conditions, there have been concerns over documented reports of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms. Gilead has provided remdesivir to pediatric patients with severe COVID-19 under the company’s compassionate use program since February of this year as well as under the US Emergency Use Authorization (EUA) granted last month.

The company is now taking additional steps to gather data on the drug in this important population. Coordinating closely with the US 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. The trial will be conducted at more than 30 sites in the US 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” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

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