POP02 Enrolls Participants in Record Speed

Family doctor examining throat of a small black boy while visiting him at home during coronavirus pandemic.

The Pediatric Trials Network (PTN), NICHD Funded, Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) Study has activated new sites in record speed.

In less than one year, the team selected approximately 60 sites and worked to activate >35 sites across the US and Canada. Site teams have overcome local challenges and enrolled almost 400 participants in the study, including those with acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C). Over 70% of these children are underrepresented minority (African Americans, Hispanic/Latinos, and American Indians/Alaska Natives) who are disproportionately impacted by the COVID-19 pandemic.

The study structure previously put in place by PTN POPS served as the supporting framework and was helpful in PTN’s ability to establish a COVID-19-focused trial (POP02-COVID sub-study) more rapidly. The fast support of sites to expedite the activation process was paramount in getting the project off the ground.

“This past year was indescribably difficult for everyone, but our study team, site staff and investigators worked tirelessly and unified efforts to help close knowledge gaps during this public health crisis. Central to these efforts are our participants. We are indebted to the families and patients who willingly participate in research to help other children,” said Chi Hornik, POP02 Principal Investigator.

In addition to evaluating the dosing and safety of drugs of interest (Anakinra, Aspirin, Azithromycin, Canakinumab, Colchicine, Interferon, Lopinavir/Ritonavir, Remdesivir, Ribavirin, Ruxolitinib, Sarilumab, Tocilizumab), the POP02-COVID study aims to evaluate combinations of therapies, risk factors, and genetic factors that influence the susceptibility, severity, and outcomes of children affected by acute COVID-19 or MIS-C.

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