News and for the UB community
COVID-19 UPDATES • 12/05/2022
Posted on June 1, 2022
Paxlovid, the COVID-19 drug developed by Pfizer, is being evaluated in Western New York on young people between the ages of 12 and 17 who weigh at least 88 pounds, have symptoms of COVID-19 infection and are at risk of developing into a serious illness.
Paxlovid, a compound of nirmatrelvir tablets co-administered with ritonavir tablets administered orally on an outpatient basis for five days, was found in a pivotal clinical trial to reduce hospitalizations or deaths by 88% compared to placebo in adults treated within five days of symptoms. beginning. The Food and Drug Administration legalized it for emergency use in high-risk patients in December 2021.
In March, Pfizer filed an overseas clinical trial to test the drug in children with symptomatic COVID-19 infection who are hospitalized but at risk of becoming a serious illness. The drug will be evaluated in approximately 140 pediatric participants at clinical trial sites around the world. world, adding UB.
Currently, those vulnerable young people have few characteristics when they test positive for COVID-19.
“This is the best example of how clinical studies at the Jacobs School can directly benefit the fitness of Western New Yorkers and especially those most at risk of seriously adapting to COVID-19,” says Allison Brashear, vice president of fitness sciences. and dean of the Jacobs School of Medicine and Biomedical Sciences.
Steven E. Lipshultz, A. Conger Goodyear Professor and Chair of Pediatrics at the Jacobs School, is the principal investigator. He was principal investigator of Pfizer’s clinical trials in his previous positions, in addition to working at Michigan Children’s Hospital at Detroit Medical Center.
For decades, Lipshultz has been a foreign leader in antiviral studies for young people. He has been researching the efficacy of antiviral drugs in young people for over 25 years, with continued investment as a principal investigator for pediatric HIV/AIDS since the 1980s.
So when he heard about Paxlovid, he became interested in its potential for young people with underlying physical conditions.
Children eligible for this trial are those who recently tested positive for COVID-19 and are symptomatic of their COVID-19 infection but have not been hospitalized, and who have at least one underlying medical characteristic or condition that puts them at risk for progressive disease. worsening of covid19 infection. For example, they may have a chronic disease, such as asthma or diabetes, or are immunocompromised, either from birth or as a result of treatment with immunosuppressive therapies, such as cancer therapies.
“As head of the pediatric branch of Kaleida Health System and its Oishei Children’s Hospital, I see which young people are coming in with COVID-19,” says Lipshultz, president of UBMD Pediatrics. “While many adults admitted to hospitals for other situations test positive for COVID-19, our doctors in Oishei see less. Nearly a portion of all young people admitted to Oishei with COVID-19 in recent months have those underlying conditions, putting them at a greater threat of gradually symptomatic COVID-19 infections. Some of them end up in our pediatric intensive care unit. So when I heard about this essay, I said, “This is really important; we have to do it here. “
A key merit of the study, Lipshultz explains, is that it is an open-label study; in other words, the child who participates will get the drug, rather than some of them receiving a placebo.
“The fact that the trial is an open trial is essential. It’s a place where studies and clinical care are harmonized,” he says.
“There are conditions in trendy medicine where studies can establish popular attention,” Lipshultz says, “and that may be the case here. What happens if a child with any of those underlying conditions contracts COVID?What are the options? Those kids get intravenous infusions of COVID antibodies, but some don’t work with the latest strains of COVID; we tested them with remdesivir, but it’s not readily available and is only for hospitalized children.
“For symptomatic young people inflamed with COVID with background situations in the outpatient world, there is no other option,” he says.
Getting the clinical trial in Buffalo far from a success, he notes, and it couldn’t have happened without the vigorous efforts of several UB administrators, starting with President Satish K. Tripathi and adding Brashear, who had been to Buffalo. Six days Lipshultz learned of Pfizer’s trial.
“The dean organized an ongoing organization and conducted several stages within the university to make all of this happen,” Lipshultz says. “Without the quick paintings of Dean Brashear and others at the UB, this would never have been possible. “
The logistics involved in conducting the clinical trial in the West New York domain were complicated, as it was necessary to know that a compromised domain contained protection and infection so that inflamed children could be away from others. Once a child has been referred to the clinical examination team through a healthcare provider, the child and his or her family are welcomed into the UB’s Pediatric COVID Clinic located within the UB’s Addiction Clinical and Research Institute at 1021 Main Street, where they can register for the test.
Lipshultz reiterates that while most children in the general population will have mild symptoms of COVID-19 or even the flu, it is imperative for the most vulnerable populations for whom those viruses are so devastating and even deadly.
“Let’s say a child is taking steroids for asthma,” he says. “They still go to school every day, but if they’re inflamed with COVID-19, they may not develop a sufficient immune response. They can also simply end up infecting the whole class. These young people pass from home and infect their parents or grandparents who can become very ill in health and even die. But if you have an effective oral treatment for those at higher chronic risk, this is one of the most important. The long-term methods we have, not only to keep those vulnerable children healthy, but also their classmates, teachers, and loved ones.
For more information on how to enroll in the clinical trial, contact coordinator Patti O’Leary at 716-829-5773 or pcoleary@buffalo. edu.
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