Researchers funded by the National Institutes of Health have launched an effort to evaluate drugs prescribed to treat COVID-19 in infants, children and adolescents across the country. The study leverages an existing clinical trial that examines drugs that are prescribed off-label to children for a variety of medical conditions. Because many drugs have not been tested specifically for use in children, physicians will often prescribe drugs off-label to children because they lack an alternative, approved treatment.
“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, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which oversees the project.
Researchers will investigate several drugs currently given to children diagnosed with COVID-19, including antiviral and anti-inflammatory drugs. Products will be added or removed from the list as researchers learn more about the treatment needs of patients with COVID-19. The study is not a clinical trial with a control group. Rather, healthcare providers who are already treating patients with drugs on the list may enroll patients whose parents or guardians have given their consent. The study is called Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care.
Researchers will analyze blood samples collected from routine medical procedures to understand how drugs move through the bodies of children, from newborns to adolescents under 21 years of age. They will also collect information on potential side effects and patient outcomes, such as the duration and type of respiratory support that may be needed and length of hospital stay. The study is designed to gather information to refine dosing and improve safety for infants, children and adolescents; it is not designed to evaluate which drug is the best treatment for COVID-19.
The study is being conducted in approximately 40 sites of the NICHD-funded Pediatric Trials Network(link is external). Importantly, many study sites are located near diverse communities, given reports that COVID-19 disproportionately affects(link is external) racial and ethnic minorities across all ages(link is external). The study also aims to analyze drug dosage and safety for special populations, including premature infants, critically ill children, children with Down syndrome and obese children.
The study is part of NICHD’s Best Pharmaceuticals for Children Act (BPCA) research program, which investigates drugs and therapies commonly prescribed to infants and children but not sufficiently tested in them. Data from BPCA studies are available to researchers through NICHD’s Data and Specimen Hub (DASH).