In record speed, the Pediatric Trials Network (PTN) worked to collaboratively and successfully stand up an extended component of the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) to focus on six drugs that have the potential to be involved in the treatment of COVID-19. The drugs are: Azithromycin, Chloroquine, Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin, and Tocilizumab. While the initial focus will begin with these six drugs, more drugs will be added soon.
“Site investigators and staff are working extremely hard during a challenging time to expedite their activation processes, and over 30 sites have eagerly joined in less than two weeks to support this effort to obtain data to guide frontline clinicians during a public health crisis such as what we are currently facing,” said Dr. Chi Hornik, POP02 Study Principal Investigator. 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 more rapidly. The fast support of sites to expedite reviews was paramount in getting the project off the ground. The study has already enrolled four participants who are currently taking one of the medications, per standard of care.
New partners such as Dr. Catherine Bendel, from the University of Minnesota, reached out to support the PTN by providing samples and assist with these efforts.
As more information is learned about COVID-19, it will be necessary to have information regarding the safety, effectiveness, and pharmacokinetics of the drugs that could be helpful in treating COVID-19 in children.
“PTN serves as a national collaborative resource, providing evidence for optimal dosing of commonly used medications in infants and children. Our expanded POP02 work will be instrumental in helping inform the decisions parents and healthcare providers make when caring for our youngest patients with COVID-19,” said Dr. Daniel Benjamin, Principal Investigator of PTN.