Researchers funded by the National Institutes of Health (NIH) have launched an effort to evaluate drugs prescribed to infants, children and adolescents across the country that were diagnosed with COVID-19.
The study uses an existing clinical trial that examines drugs that are prescribed off-label to children for a variety of medical conditions.
An off-label drug is a type of medication that is being used in a manner not specified in the FDA's approved packaging label criteria. Every prescription drug marketed in the U.S. carries an individual FDA-approved label.
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.
The NIH has made clear that this is not a clinical trial. Healthcare providers who are already treating patients with drugs on the list in this study may enroll their patients whose parents or guardians have given their consent. The study is called Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care.
Blood samples collected from patients will be analyzed to understand how the drugs move through the bodies of children with ages ranging from newborns to adolescents under the age of 21.
Information on potential side effects and patient outcomes will also be recorded. Things such as the duration and type of respiratory support that was needed and the length of the patient’s hospital stay will all be taken into account.
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, according to the NIH.
The study is being conducted in approximately 40 sites of the NICHD-funded Pediatric Trials Network. Many study sites are located near diverse communities, given reports that COVID-19 disproportionately affects racial and ethnic minorities across all ages. 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).