The phase 2/3 trials will evaluate remdesivir (Gilead) in pediatric patients, from newborns to adolescents, who have contracted severe COVID-19 symptoms.
Gilead Sciences announced its plan to begin pediatric enrollment for a new phase 2/3 clinical trial, which will assess remdesivir for treating pediatric patients with moderate-to-severe novel coronavirus disease 2019 (COVID-19).
According to Merdad Parsey, MD, PhD, chief medical officer for the company, Gilead’s pediatric study was made in response to concerning reports of children being hospitalized with COVID-19 and related autoimmune symptoms.
Parsey noted that Gilead has been offering remdesivir to pediatric patients with severe manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through their compassionate use program, which began in February.
Remdesivir is a nucleotide analog with broad-spectrum antiviral activity against various emerging viral pathogens. The drug has been offered for COVID-19 symptoms through the compassionate use program, enrollment in a Gilead clinical trial, an expanded access program, and, most recently, through the FDA’s Emergency Use Authorization.
In early June, Gilead announced its SIMPLE phase 3 trial results, which found 5-day remdesivir treatment to be 65% more likely to show clinical improvement compared with standard of care. Over the course of the pandemic, the company has demonstrated its commitment to providing treatment options for Americans with the virus, as they donated 607,000 vials of remdesivir to the United States government.
Though COVID-19 mostly affects adults, particularly older adults and those with comorbid conditions, Gilead highlights that their latest study would center around “this important population” of pediatric patients.
The multi-site, open-label, single-arm, phase 2/3 clinical trial plans to enroll an estimated 50 pediatric patients with moderate-to-severe COVID-19 symptoms, including newborns through adolescents less than 18 years of age. Trials will be pursued in the United States, as well as in Europe. Gilead is not yet recruiting for the trials, but more information regarding specific study arms and outcome measures can be found here.
“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,” Parsey said in the statement.