PTN Studying Multi-System Inflammatory Syndrome in Children

While there have been relatively few confirmed cases and deaths from COVID-19 in children, researchers have been reporting an increased incidence of multi-system inflammatory syndrome in children (MIS-C) that is associated with prior or concurrent SARS-CoV-2 infections in children. Between March and October 1, 2020, over 1,000 MIS-C patients were reported from 44 state health departments, the District of Columbia, and New York City. The cases seem to be disproportionately affecting Black and Latino children. According to the CDC,

  • 41% were Hispanic or Latino
  • 35% were Black
  • 14% were non-Hispanic White

The average age for these patients was 8 years old, and obesity was the most commonly reported underlying medical condition, occurring in 30.5% of Hispanic, 27.5% of Black, and 6.6% of White MIS-C patients according to CDC data published in August.

The Pediatric Trials Network (PTN) is poised to prospectively gather data from children with COVID-19 and MIS-C and how best to treat them. The NICHD-funded Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) Study continues to evolve in an effort to support the treatment of younger COVID-19 patients. POP02 is evaluating several therapeutics to potentially treat COVID-19 in patients age 0 – <21 years old. About 60 different sites across the United States and Canada are being selected to participate in this important research.

Dr. Chi Hornik, POP02 study principal investigator, said that this platform and the opportunistic design of the study helps researchers find urgent answers on how these therapeutics work in children by enrolling a wide and diverse cohort of children.  “Some asymptomatic patients are presenting weeks later with MIS-C. We need more information, as quickly as possible, to help clinicians and families make the best decisions on treatment for children affected by acute COVID-19 as well as MIS-C,” she said adding. “We need to find the right dose and combination of treatments to ensure safety with optimal outcomes in all affected children.”

Of the affected children who have been enrolled in POP02, approximately 75% of them are from minority populations. “This pandemic is hitting communities of color disproportionately hard which is why a broad, national platform like POP02 is so important,” said Hornik.

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