PTN to Study Pediatric Dosing for Potential COVID-19 Drugs

In response to the COVID-19 pandemic, the POP02 study has expanded its protocol to include antiviral drugs that could be used to treat pediatric patients with COVID-19.

The Pediatric Trials Network (PTN) is expanding one of its existing studies to focus on pediatric dosing for six antiviral drugs that may be used in the treatment of COVID-19.

In a matter of weeks, Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POP02), was able to expand its protocol to focus on potential COVID-19 therapies and begin enrolling pediatric patients who are already taking these medications per standard of care. POP02 will collect data on azithromycin, chloroquine, hydroxychloroquine, lopinavir/ritonavir, ribavirin, and tocilizumab. The study, which will be led by Duke’s Chi Hornik, PharmD, Director of Clinical Research in the Division of Pediatric Critical Care Medicine, will include about 30 sites. Researchers aim to enroll 36 patients taking each drug.

The PTN, for which the DCRI serves as a coordinating center, is a research network focused on determining safe and effective drug dosing standards for children.

POP02 is an extension of another PTN study, PTN POPS. The aim of both studies is to leverage procedures conducted during routine patient care, such as blood draws, and use pharmacokinetic modeling to determine safe and effective dosing information for different pediatric age groups and special pediatric populations.

“PTN serves as a national collaborative resource, providing evidence for optimal dosing of commonly used medications in infants and children,” said Danny Benjamin, MD, PhD, MPH, principal investigator and chair of the PTN. “Our expanded POP02 work will be instrumental in helping inform the decisions parents and healthcare providers make when caring for our youngest patients with COVID-19.”