ATLANTA (August 8, 2022) – The COVID-19 pill, Paxlovid, aimed at preventing hospital admission in COVID-19 positive patients will be tested in children under age 18 during a global clinical trial, where Children’s Healthcare of Atlanta will serve as a testing site led by Pediatric Emergency Medicine Physicians Mark Griffiths, MD and Claudia Morris, MD. The Pfizer oral anti-viral medication received emergency use authorization for ages 12 and up in December 2021 and data has shown that about 90% of patients treated in that age group did not require hospital admission.
“COVID-19 therapies to date are not easily accessible for kids, as most are IV medications, or they are only approved for ages 18 and older,” says Dr. Griffiths, who is also an Assistant Professor in the Department of Pediatrics at Emory University School of Medicine. “At Children’s, we have every demographic you could possibly want in one healthcare system to complete this study to determine if this COVID-19 therapy should be made widely available to children. We’ve got the people. We’ve got the resources. We’ve got the affiliations.”
Children with a positive COVID-19 test result who are at high risk for progression to severe COVID-19, including hospitalization or death, as determined by their care providers, will be eligible for the trial. This may include patients with underlying medical conditions like asthma, obesity or diabetes, those receiving chemotherapy, and those taking immune-suppressant drugs. The Phase 2 safety and efficacy trial will test 140 patients at more than 60 sites around the world for a year and a half. Participants will receive a five-day course of Paxlovid within 72 hours of diagnosis and undergo a series of blood draws to determine the pharmacometrics of the drug in the blood. Enrollment will take place at Children’s Healthcare of Atlanta Egleston Hospital with follow-up visits at the Center for Advanced Pediatrics’ Pediatric Research Unit.
Currently, only 1.9% of patients hospitalized with COVID-19 are children but their symptoms are often different, according to Dr. Griffiths. “We have seen kids experience more gastrointestinal issues, such as vomiting, diarrhea and dehydration, rather than respiratory concerns, and the development of MIS-C or multisystem inflammatory syndrome in children can also occur.”
Dr. Griffiths hopes the COVID-19 Paxlovid pill will eventually be an option for kids who are not vaccinated to reduce their chances of hospital admission. He also believes it could be a helpful follow-up medication to take after receiving a positive COVID-19 test result. “The hope is that this will provide evidence for an effective treatment that can be taken as soon as parents know their child is positive to prevent worsening symptoms leading to hospitalization,” he says.
After the trial and pending positive results, Pfizer may apply to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of Paxlovid to be made available to kids under age 12.
About Children's Healthcare of Atlanta
As the only freestanding pediatric healthcare system in Georgia, Children’s Healthcare of Atlanta is the trusted leader in caring for kids. The not-for-profit organization’s mission is to make kids better today and healthier tomorrow through more than 60 pediatric specialties and programs, top healthcare professionals, and leading research and technology. Children’s is one of the largest pediatric clinical care providers in the country, managing more than one million patient visits annually at three hospitals, Marcus Autism Center, the Center for Advanced Pediatrics, urgent care centers and neighborhood locations. Consistently ranked among the top children’s hospitals by U.S. News & World Report, Children’s Healthcare of Atlanta has impacted the lives of kids in Georgia, across the United States and around the world for more than 100 years thanks to generous support from the community.
About Emory University School of Medicine
Emory University School of Medicine is a leading institution with the highest standards in education, biomedical research and patient care, with a commitment to recruiting and developing a diverse group of students and innovative leaders. Emory School of Medicine has more than 2,800 full- and part-time faculty, 556 medical students, 530 allied health students, 1,311 residents and fellows in 106 accredited programs, and 93 MD/PhD students in one of 48 NIH-sponsored Medical Scientist Training Programs. Medical school faculty received $456.3 million in external research funding in fiscal year 2018. The school is best known for its research and treatment in infectious disease, neurosciences, heart disease, cancer, transplantation, orthopaedics, pediatrics, renal disease, ophthalmology and geriatrics.