The company that makes the antiviral drug remdesivir, used to treat coronavirus, says it is about to start advanced trials of the drug in children.
Gilead Sciences said it was starting a phase 2/3 trial in 50 pediatric patients with moderate to severe Covid-19 who are in the hospital. These trials are meant to assess safety and efficacy. Children from babies on up will be eligible for the trial, being run at 30 sites in the US and Europe.
Remdesivir, which is infused, is the only drug that has US Food and Drug Administration emergency authorization for use in treating coronavirus infections.
Gilead has treated pediatric patients with remdesivir since February under compassionate use program.
“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. 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,” the company said in a statement.
A recent study funded by Gilead found that moderately ill Covid-19 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.