Following the emergency use authorization given to Remdesivir on May 1, Gilead Sciences has announced that it will conduct a clinical trial of the drug on children.
While older people are more likely to experience negative COVID-19 symptoms than children, an analysis of 1.3 million cases between January 22 and May 30 found that children aged nine and below have an incidence rate of 51 cases per 100,000 people.
Although rare, children who contract the condition tend to develop multisystem inflammatory syndrome- a condition that inflames blood vessels throughout the body and may cause the failure of one or more organs.
To help children at risk of this condition, Gilead plans to assess the drug's safety, tolerability, and efficacy in around 50 children suffering from moderate to severe COVID-19 symptoms. The company plans on including newborns and adolescents at over 30 sites between the US and Europe. Patient enrolment will begin soon, and the trial is expected to be finalized by the end of the year.
The trial's success will be measured by the proportion of pediatric patients who will experience negative effects from the treatment and abnormalities as assessed by a lab. The researchers will also monitor plasma concentrations of Remdesivir and metabolites.
"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." says Merdad Parsey, the chief medical officer of Gilead Sciences.
Remdesevir has been used to treat pediatric patients suffering from severe COVID-19 symptoms since February under the company's compassionate use program.
Granted emergency use authorization by the FDA last month, the drug is currently the only drug that has approval for usage against COVID-19. This comes after the FDA withdrew its authorization for antimalarial drugs Chloroquine and Hyrdoxychloroquine following recent studies demonstrating their ineffectiveness in treating COVID-19.