Rutgers will enroll children with symptomatic cases of COVID-19 who are at risk of serious illness
Rutgers has been selected as the clinical trial site for Pfizer’s global research study to assess the safety and efficacy of a potential oral antiviral treatment for children under 18 with COVID-19 who have health conditions that put them at risk of serious illness.
The Phase 2/3 clinical trial will assess the pharmacokinetics, safety and tolerability of the treatment – a combination of the drugs nirmatrelvir and ritonavir marketed as “Paxlovid” – to identify the appropriate dose for each group of pediatric age.
Children with certain risk factors – such as those who are overweight or actively smoke or have 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 complications of COVID-19.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of many global pediatric study sites for Pfizer. Researchers are looking to recruit up to 150 children who have a confirmed diagnosis of COVID-19 within 72 hours of enrollment and a first 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 participate in eight study visits over five weeks.
“The trial will be convenient for families,” said lead researcher Cassandra Louis, assistant professor in the department of pediatrics at Rutgers Robert Wood Johnson Medical School. “After an initial in-person visit to the clinical trial site, clinicians will visit participants in their homes to monitor progress and collect blood samples with a micropuncture device that causes minimal pain or discomfort. .”
A clinical trial for adults has already demonstrated the safety and efficacy of the drug: participants who received the treatment within five days of the onset of symptoms had an 88% reduction in the risk of hospitalization or death related to COVID-19. Based on these results, 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 of age and older who weigh at least less than 88 pounds and are at risk of progression to severe cases of COVID-19.
“Although children who were considered to have an adult weight were included in the FDA’s emergency use authorization, people under the age of 18 were not included in the adult clinical trial,” Louis said. “This trial will provide more information about how this treatment prevents serious illness in children and adolescents.”
Rutgers was previously selected as the clinical trial site for the Pfizer-BioNTech global research study to assess the effectiveness of its COVID-19 vaccine in children.