NIH Study to Evaluate Drugs Prescribed to Children with COVID-19

Researchers funded by the National Institutes of Health (NIH) have launched an effort to evaluate drugs prescribed to treat coronavirus disease 2019 (COVID-19) in infants, children, and adolescents across the United States.

The study leverages an existing clinical trial that examined drugs prescribed off-label to children for a variety of medical conditions. Many drugs have not been tested specifically for use in children, leading physicians to often prescribe drugs off-label to children due to a lack of alternative approved treatments, according to an NIH press release.

“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 National Institute of Child Health and Human Development, which oversees the project.

The research 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.

According to an NIH press release, the study is not to be considered a clinical trial with a control group. Rather, health care providers who are already treating patients with drugs on the list may enroll patients whose parents or guardians have given their consent.

Blood samples will be analyzed from routine medical procedures to understand how drugs move through the bodies of children, from newborns to adolescents under 21 years of age. Researchers will also collect information on potential adverse effects and patient outcomes, such as the duration and type of respiratory support that may be needed and length of hospital stay, according to an NIH press release.

The study is designed to gather information to refine dosing and improve safety for infants, children, and adolescents, and not to evaluate which drug is the best treatment for COVID-19. Many of the approximately 40 study sites are located near diverse communities, given reports that COVID-19 disproportionately affects racial and ethnic minorities across all ages.

In addition, the study aims to analyze drug dosage and safety for special populations, including premature infants, critically ill children, children with Down syndrome, and obese children.

REFERENCE

NIH-funded study to evaluate drugs prescribed to children with COVID-19. NIH. https://www.nih.gov/news-events/news-releases/nih-funded-study-evaluate-drugs-prescribed-children-covid-19. Published June 10, 2020. Accessed June 10, 2020.