Gilead said June 17 it plans to conduct a pediatric clinical trial of its antiviral drug, remdesivir, which has been shown to shorten COVID-19 patients' recovery time.
In coordination with the FDA, Gilead will test remdesivir in about 50 pediatric patients with moderate to severe COVID-19. The trial will include newborns through adolescents.
The trial will be conducted at more than 30 sites in the U.S. and Europe, Gilead said. The drugmaker expects to start the study this month and complete it in December.
"While the novel coronavirus appears to disproportionally affect adults – especially the elderly and those with underlying health conditions – concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms," said Merdad Parsey, MD, PhD, Gilead's chief medical officer.
"Gilead has provided remdesivir to pediatric patients with severe COVID-19 under our compassionate use program since February of this year, as well as under the U.S. emergency use authorization granted last month, and we are now taking additional steps to gather data on the drug in this important population."