Vanderbilt University Medical Center, in collaboration with the University of Colorado and Beth Israel Deaconess Medical Center in Boston, is leading one of the first “telemedicine” clinical trials to test a potential treatment for COVID-19.
The trial, called TREAT NOW, is testing whether lopinavir/ritonavir, an antiviral drug combination approved for HIV disease, can reduce the severity of illness in people with early-confirmed COVID-19. North Chicago-based pharmaceutical company AbbVie, which makes the antiviral combination, is sponsoring the study.
While previous clinical trials have shown that lopinavir/ritonavir provides no benefit in patients hospitalized for severe COVID-19 complications, preclinical studies suggest the antiviral combination can inhibit the SARS-CoV-2 virus, which causes COVID-19.
“The thought is that the earlier you treat, the better off you are,” said Todd Rice, MD, MSc, associate professor of Medicine, who is leading the study at VUMC.
“If we can use something that is already available and is easy to take to prevent patients from getting sick enough that they need the hospital, that seems like a home run for the care of these patients,” he said.
A unique aspect of the study is that it is completely “touch free,” Rice said.
Study volunteers, who are likely self-quarantining at home after testing positive for COVID-19, sign an electronic consent form and are randomized to receive either the drug combination or inactive placebo. The pills are shipped to them overnight, and they report how they’re doing daily via a smartphone app or texting.
“If everything goes as planned, we never see these people,” Rice said. “They don’t have to leave home. It’s clearly an innovation in (clinical) trials that could work for non-COVID research, too.”
Patients are eligible to participate in the study if they have less than a week of symptoms and laboratory-confirmed COVID-19. For more information, send an email to Rice at todd.rice@vumc.org or study coordinator Margaret Hays at margaret.hays@vumc.org.
The study, which aims to enroll 600 participants nationwide, is being run by the Vanderbilt Coordinating Center. Wesley Self, MD, MPH, associate professor of Emergency Medicine at VUMC, is also participating.
Co-principal investigators of TREAT NOW are Nathan Shapiro, MD, at Beth Israel, and Adit Ginde, MD, at the University of Colorado. The University of Mississippi Medical Center in Jackson is also participating in the study.