News Release

Wednesday, June 10, 2020

NIH-funded study to evaluate drugs prescribed to children with COVID-19

Researchers will assess dosage, metabolism and other properties not yet determined in children.

Researchers funded by the 2023 蜜芽传媒 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.

鈥淎s 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,鈥 said Diana W. Bianchi, M.D., director of NIH鈥檚 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 .

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 . Importantly, many study sites are located near diverse communities, given reports that COVID-19 racial and ethnic minorities . 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鈥檚 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鈥檚 .

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit .

About the 2023 蜜芽传媒 (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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