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Focus is on drugs, including monoclonal antibody medications, that received emergency use authorizations early in pandemic
By the University at Buffalo
Vaccinations may be front-page news these days, but clinicians are well aware that an effective treatment for COVID-19, especially for patients who don’t require hospitalization, is still sorely needed.
“Unfortunately, COVID-19 isn’t going away anytime soon,” said Brian Clemency, D.O., professor of emergency medicine in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. He noted that, while vaccinations are critical, plenty of people are still testing positive, especially as new variants emerge.
“As the country starts opening up again, we will most likely see an increase in infections in young adults, people in their 20s and 30s who probably don’t have comorbidities,” he said.
To find an effective medication for mild to moderate cases in non-hospitalized patients, Clemency is leading a National Institutes of Health program at UB that is testing drugs, including several monoclonal antibody medications, in people with mild to moderate cases of COVID-19.
“A number of drugs are already out there under emergency use authorizations,” said Clemency, noting that, during the earlier surges of the pandemic, it was, of course, critical to get those medications approved under EUAs. “We rushed to make those treatments available under those circumstances, but we still need to do the kinds of rigorous, long-term, large-scale definitive research studies that we normally do to confirm safety and efficacy.”
That’s what the new, randomized, blinded clinical trial at UB, called ACTIV-2, is designed to do.
“This study is part of a giant national effort to bring evidence-based medicine to the monoclonal antibody drugs that were approved under the EUAs,” Clemency said. “The best way to do that is to get a diverse patient population to quickly run a megastudy among different national sites at once. This is the kind of rigorous study we need to do now with COVID-19.”
Mild to Moderate Cases with at Least One Symptom
The UB researchers are seeking between 50 and 100 adults who tested positive in the past 10 days and who have experienced at least one of a number of symptoms in the past eight days. They began recruiting last week.
The full eligibility description is available at https://www.riseabovecovid.org/en/. Potential participants can also call or text 716-427-6643 to find out if they are eligible.
The study is being run out of DeGraff Memorial Hospital and Erie County Medical Center, but it requires only one visit to the hospital at the start of enrollment. After that, the project will send a nurse to each participant’s home for follow-up testing and reporting of symptoms. The trial will last up to 72 weeks, but most interactions will occur during the first four months of participation.
“Our focus is on non-hospitalized patients,” Clemency said. “We want to find an infusion or other medication that can help patients with COVID-19 get better without hospitalization sooner to better protect patients and hospital resources.
“What’s unique here is that this is a truly national study where patients who meet the study criteria, give their consent to participate and then, depending on their overall health and whether or not they have comorbidities, they will then be enrolled into one of four different drug arms of the study,” Clemency explained.