By the University at Buffalo
Paxlovid, the COVID-19 medicine developed by Pfizer, is being evaluated in Western New York in children ages 12 to 17 who weigh at least 88 pounds, are symptomatic with COVID-19 infection, and who are at risk of progression to severe disease.
Paxlovid, comprised of nirmatrelvir tablets that are co-administered with ritonavir tablets that are administered orally in the outpatient setting over five days, has been shown in a pivotal clinical trial to reduce hospitalization or death by 88% compared to placebo in adults treated within five days of symptom onset. The Food and Drug Administration authorized it for emergency use in high-risk patients in December 2021.
In March, Pfizer initiated an international clinical trial to test the drug in children with symptomatic COVID-19 infection who are not hospitalized but are at risk of progression to severe disease. The drug will be tested in approximately 140 pediatric participants at clinical trial sites globally, including the University at Buffalo.
Right now, these vulnerable children have few options when they test positive for COVID-19.
“This is a perfect example of how clinical research at the Jacobs School may directly benefit the health of Western New Yorkers and specifically those most at risk of becoming severely ill with COVID-19,” said Allison Brashear, M.D., vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences.
Steven E. Lipshultz, M.D., A. Conger Goodyear Professor and chair of pediatrics in the Jacobs School, is principal investigator. He was a principal investigator on Pfizer clinical trials in his previous positions, including at Children’s Hospital of Michigan of the Detroit Medical Center.
A Leader in Pediatric Antiviral Research
For decades, Lipshultz has been an international leader in antiviral research for children. He has been studying the effectiveness of antiviral drugs in children for more than 25 years, with continuous funding as a principal investigator for pediatric HIV-AIDS since the 1980s.
So, when he learned about Paxlovid, he was immediately interested in its potential for children with underlying health conditions.
Children eligible for this trial are those who recently tested positive for COVID-19 and are symptomatic from their COVID-19 infection but haven’t been hospitalized, and who have at least one characteristic or underlying medical condition that makes them at risk for progressively worsening COVID-19 infection. For instance, they may have a chronic condition, such as asthma or diabetes, or are immunodeficient, either from birth or from treatment with immunosuppressive therapies, such as anti-cancer therapies.
“As the pediatric chief of service for the Kaleida Health System and its Oishei Children’s Hospital, I see which kids are getting admitted with COVID-19,” said Lipshultz, who is president of UBMD Pediatrics. “While many adults admitted to hospitals for other conditions are often found to be COVID-19 positive incidentally, our doctors at Oishei see fewer of those. Almost half of all kids admitted to Oishei with COVID-19 over the past few months have these underlying conditions, placing them at higher risk for progressively symptomatic COVID-19 infections. Some of them wind up in our pediatric intensive care unit. So, when I learned about this trial, I said, ‘This is really important; we need to be doing this here.’ ”
A key advantage of the study, Lipshultz explained, is that it is an open label study; in other words, every child who participates will get the drug, as opposed to some of them receiving a placebo.
“The fact that the trial is an open label trial is critical. This is a situation where research and clinical care are harmonized,” he said.
Where Research May Define the Standard of Care
“There are situations in modern medicine where research may define the standard of care, and this may be the case here,” Lipshultz said. “What happens if a child with one of these underlying conditions gets COVID? What are the options? We have given these kids intravenous COVID antibody infusions, but some don’t work with the more recent COVID strains; we have tried them with remdesivir, but that’s not readily available and that’s only been for kids who are hospitalized.
“For COVID-infected symptomatic kids with underlying conditions in the outpatient world, no other option exists.”
Getting the clinical trial in Buffalo was far from a slam dunk, he noted, and it couldn’t have happened without the vigorous efforts of a number of UB administrators, starting with President Satish K. Tripathi and including Brashear, who had been in Buffalo all of six days when Lipshultz heard about the Pfizer trial.
“The dean immediately organized a working group and pushed several units within the university to make all this happen,” Lipshultz said. “Without the fast work by dean Brashear and others at UB, this never would have been possible.”
The logistics involved in conducting the clinical trial in the Western New York area were complicated, since a dedicated space needed to be identified to maintain safety and infection control so that infected children could be isolated from others. Once a child has been referred to the clinical study team by a health care provider, the child and family are greeted at the UB Pediatric COVID Clinic located inside the UB Clinical and Research Institute on Addictions building at 1021 Main St., where they can enroll in the trial.
Lipshultz reiterated that, while most children in the general population will experience mild symptoms from COVID-19 or even the flu, it is critical to protect the most vulnerable populations for whom these viruses are so devastating and possibly even lethal.
“Let’s say a child is on steroids for asthma,” he said. “They still go to school every day, but if they’re COVID-19 infected, they may not mount a sufficient immune response. They could end up infecting the whole classroom. Those kids go home and infect their parents or grandparents who can get very sick and even die. But if you have an effective oral therapy for those who are at chronic high risk, that is one of the most important long-term strategies we have – not only to keep these vulnerable kids healthy, but also to protect their classmates, teachers and loved ones.”
For information on enrolling in this clinical trial, contact study coordinator Patti O’Leary at 716-829-5773 or [email protected].