COVID Drug Study Seeks Children, Teens For Testing At Rutgers

NEW BRUNSWICK, NJ — Pharmaceutical giant Pfizer has again selected Rutgers University as a clinical trial site, this time to determine the correct dosage of Paxlovid that Pfizer should recommend for children.

Paxlovid is the oral antiviral coronavirus treatment developed by Pfizer. Paxlovid is a combination of the medications nirmatrelvir and ritonavir.

In December, the FDA granted Paxlovid emergency-use authorization. However, as the Paxlovid pill is becoming increasingly prescribed worldwide, some doctors and patients are reporting COVID relapses or a "rebound" of symptoms, something Pfizer said they are investigating.

Rutgers often partners with pharmaceutical companies on clinical trials:

In the summer and fall of 2021, Rutgers University was a clinical trial site for the Pfizer-BioNTech coronavirus vaccine for children, toddlers and infants, and parents across New Jersey submitted their children to be used for the trials.

Rutgers was also a trial site for Johnson & Johnson's vaccine, and Rutgers college students participated in the trial. (The FDA has now severely limited use of the Johnson & Johnson vaccine because of the risk of a dangerous clotting condition called thrombosis with thrombocytopenia syndrome after getting the vaccine.)

In this new Paxlovid trial, 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.

Rutgers is specifically looking for children under 18 who have health conditions that put them at risk for severe illness, such as children or teens 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.

All of these children/teens are at an increased risk of hospitalization or death from COVID-19 complications.

These are the children Rutgers and Pfizer want to study in this new trial. If you are interested in having your child participate in the study, visit COVIDpillstudy.com

The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of multiple worldwide sites chosen by Pfizer for their pediatric study.

“The trial will be convenient for families,” said principal investigator Dr. 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.”

Adult patients who are given Paxlovid within five days of symptom onset had an 88 percent reduction in risk of COVID-19-related hospitalization or death, according to Pfizer.

“This trial will provide more information on how this treatment prevents severe disease in children and teens," said Dr. Louis.

Prior: Rutgers Launches Infant, Toddler COVID Vaccine Trial (Nov. 2021)

Rutgers Now Enrolling Children 6 Months And Up In Pfizer Trial (May 2021)

Rutgers Students Wanted For Johnson & Johnson's Vaccine Trial (November 2020)

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