Gilead Sciences Inc, which makes the antiviral drug remdesivir and is now testing it for potential coronavirus treatment, said on Wednesday it is about to start advanced trials of the drug in children.
The U.S. firm said it was starting a phase 2/3 trial in 50 pediatric patients with moderate to severe coronavirus who are in the hospital. These trials are aimed at assessing safety and efficacy. Children from babies on up will be eligible for the trial, being run at 30 sites in the United States and Europe, Gilead said.
Remdesivir, which is infused, is the only drug that has obtained U.S. Food and Drug Administration’s (FDA) emergency authorisation for use in treating coronavirus infections.
Gilead has treated pediatric patients with remdesivir since February under compassionate use programme.
“From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of COVID-19, in parallel with emerging knowledge about the disease.” the company said in a statement.
“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 hospitalised with COVID-19 and related autoimmune symptoms,”
A recent study funded by Gilead found that moderately ill coronavirus patients who received a five-day course of remdesivir were more likely to have clinical improvement after 11 days compared to those who received traditional standard of care alone, according to the company’s release.