“When I first saw the results, I was so excited that I was speechless,” said lead author Kathleen Mullane, DO, PharmD, director of infectious disease clinical trials at the University of Chicago Medicine, about the data presented on July 13 at COVID-19 2020, the first international conference of its kind. “All of us here at the University of Chicago are working to make sure we provide the best care possible to our patients. These results show that we did a good job, and that we’re able to contribute to better outcomes for the population of people we serve. It was very encouraging.”
Recent data has demonstrated significant racial disparities both in the rate of COVID-19 cases and in the number of deaths caused by the disease. In particular, Black patients are twice as likely as white patients to test positive for COVID-19, the disease caused by SARS-CoV-2. This is likely due to a variety of socioeconomic factors and existing disparities in healthcare access.
Remdesivir, a broad-spectrum antiviral medication, is metabolized by the body and broken down into GS-441524 triphosphate, a molecule that prevents viruses from replicating. Early clinical trial results were mixed, but more recent data from the National Institutes of Health indicate that remdesivir can shorten the recovery time in patients hospitalized with COVID-19. Shorter recovery times mean shorter hospital stays, which is generally associated with better patient outcomes and reduced healthcare costs. These results, along with evidence that there are few major negative side effects, have led to an Emergency Use Authorization by the Food and Drug Administration of remdesivir for treating COVID-19.
In this most recent analysis, using data from a large clinical trial sponsored by Gilead Sciences conducted across many institutions, researchers compared the rates of hospital discharge, improvement in clinical scores, and mortality across racial groups among a subset of U.S. patients who had received remdesivir treatment during their hospitalizations (229 patients total). While there was some disparity in risk factors — for example, Non-Hispanic White (NHW) patients showed the highest rate of cardiovascular disease and Black patients were significantly more likely to be more obese — once those factors had been accounted for, all racial groups showed similar rates of clinical improvement.
The researchers take these results as evidence that overall quality of care makes a big difference in clinical outcomes when it comes to COVID-19.
“Overall, it’s probably not just the drugs, it’s also the care that our patients received,” said Mullane. “Here at UChicago, we were treating a high percentage of the African American patients who were participating in the study — over half. We were very aggressive with our anti-infective treatment approach. Our pulmonologists used high-flow oxygen right away and avoided intubating people early, preferring to use a helmet for oxygenation, to reduce trauma to the lungs.
“It was also important that we got people started as soon as possible on remdesivir therapy,” she added. “We were screening everyone who came into the ER, trying to determine who was COVID-19 positive and might be eligible for participation in the trial. Every aspect of care was incredibly orchestrated to do our best in managing our patient’s health.”
The researchers are optimistic about what this means for remdesivir therapy in the future, including its potential as an outpatient treatment for patients who may have the virus but aren’t sick enough to be hospitalized.
“If we were able to treat people earlier, we might be able to do even better,” Mullane said. “We want to start therapy while the virus is present and actively replicating, not after it’s cleared and the immune system has gone haywire.”
These results also demonstrate the value of clinical trials in identifying new treatment options for diverse patient populations; while many studies lack accurate representation of U.S. racial demographics, these data allowed the researchers to look at outcomes across multiple patient populations.
“Patients had to agree to participate in the study, and we really have to thank our patients here at UChicago for being a part of this and agreeing to receive treatment with this drug,” said Mullane. “This study has helped people across the country and, hopefully, around the world. These patients are heroes.”
While remdesivir is one option for treating COVID-19, Mullane and her team are looking forward to their next research steps.
“Everyone on my team and everyone who has participated in the clinical trials have worked so hard to make this happen,” she said. “Patients, doctors, pharmacists, regulatory staff and even the folks working on data input and analysis — we’ve all been working really hard to analyze all this data and figure out our most promising next steps.
“We’re going to be involved in a number of important studies in the coming months,” continued Mullane. “Treating patients at earlier stages of the disease, working on prevention efforts and, of course, the vaccine trials to prevent people from getting sick in the first place will be our best defense against this coronavirus infection and preventing the spread of COVID-19.”
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