A study to evaluate medications prescribed to pediatric patients with coronavirus disease 2019 (COVID-19) is being conducted as part of the National Institute of Child Health and Human Development (NICHD)’s Best Pharmaceuticals for Children Act research program.
The study, which will be conducted in approximately 40 sites of the NICHD-funded Pediatric Trials Network, will include pediatric patients under 21 years of age. Healthcare providers already treating patients for COVID-19 with investigational therapies can enroll their patients into the study.
Blood samples from pediatric patients taken during routine medical care will be analyzed to characterize the pharmacokinetics of these agents, as specific dosing and safety data are often lacking for this patient population. As more information becomes available, drugs will be added or removed from a list of potential therapies. Information on patient outcomes (ie, duration and type of respiratory support, length of hospital stay) as well as adverse effects will also be collected.
Unlike a clinical trial with a control group, the study will focus on collecting data in order to identify appropriate and safe doses; it will not be evaluating the best treatment for COVID-19. The trial will aim to include all children including premature infants, critically ill patients, children with Down syndrome, and obese children.
“As we search for safe and effective therapies for COVID-19, we want to make sure that we do not overlook the needs of our youngest patients who may respond differently to these drugs, compared to adults,” said Diana W. Bianchi, MD, director of NIH’s Eunice Kennedy Shriver NICHD.
For more information visit nih.gov.