Rutgers University has been selected as a clinical trial site for the global Pfizer research study to evaluate the safety and efficacy of a potential oral antiviral treatment for children under 18 years old with COVID-19 who have health conditions that put them at risk for severe illness.
The phase 2/3 clinical trial will evaluate the pharmacokinetics, safety and tolerability of the treatment — a combination of the medications nirmatrelvir and ritonavir branded under the name “Paxlovid” — to identify the appropriate dose for each pediatric age group.
Children with certain risk factors — such as those who are overweight or actively smoke, or have an immunosuppressive disease, cardiovascular disease, kidney disease, neurodevelopmental disorders, active malignancy, Type 1 or 2 diabetes, hypertension, chronic lung disease or sickle cell disease — are at increased risk of hospitalization or death from COVID-19 complications.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of multiple worldwide sites for the Pfizer pediatric study. Researchers seek to recruit up to 150 children who have a confirmed diagnosis of COVID-19 within 72 hours of enrollment and an initial onset of symptoms within five days, with at least one symptom at enrollment.
Children who meet the eligibility requirements for this study will take Paxlovid twice a day for five days and will participate in eight study visits over five weeks.
“The trial will be convenient for families,” said principal investigator Cassandra Louis, an assistant professor in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School. “After an initial in-person visit at the clinical trial site, clinicians will visit participants at their homes to monitor progress and take blood samples with a micropuncture device that causes minimal pain or discomfort.”
An adult clinical trial already has demonstrated the safety and efficacy of the drug: Participants who received the treatment within five days of symptom onset had an 88% reduction in risk of COVID-related hospitalization or death. Based on these findings, the Food and Drug Administration in December granted Paxlovid emergency use authorization for the treatment of mild-to-moderate COVID-19 in adults and children 12 years and older who weigh at least 88 pounds and are at risk for progression to severe cases of COVID-19.
“Although children who are at what is considered an adult weight were included in the FDA’s emergency use authorization, people under 18 were not part of the adult clinical trial,” Louis said. “This trial will provide more information on how this treatment prevents severe disease in children and teens.”