UT Southwestern Medical Center researchers are investigating existing, available drugs that could potentially help treat mild to moderate COVID-19 cases. This move by the number one hospital in Dallas and second in all of Texas reflects a growing recognition by researchers and clinicians that stopping COVID-19 from progressing to a more severe state is of paramount importance. Now the UT Southwestern is putting this urgency to action by opening up an outpatient COVID-19 trial site next to their COVID-19 drive-thru testing site right on the campus.
Focus on Containing the Disease Early
A growing recognition that the disease must be contained early now sets in the United States. TrialSite News covers research around the world; and in low-to middle-income countries (LMICs) with less capital and resources, this recognition was internalized earlier on. In the U.S, and other wealthy nations, the popular culture centers attention on vaccines and sophisticated biological-based treatments. As compelling as these approaches sound—and indeed are—the reality is that America is the epicenter of this pandemic. Clearly a focus on finding treatments to reduce the severity and help prevent disease escalation can make a difference moving forward.
This represents a shift in mindset that, depending on what happens with the first wave of vaccine candidates, could intensify. Now UT Southwestern begins to educate patients as they come on campus via flyers and other tools.
The associate dean of clincial research at UT Southwestern Medical Center reported, “What we want to do is get those patients who may need those medications early on, which is usually within the first week of symptoms and definitely within the first few days after they have a positive diagnosis of COVID.”
Bianca Castro with 5NBC recently reported on the research ongoing geared toward treating and managing COVID-19 early on.
Therapies Under Investigation
UT Southwestern is conducting clinical trials with the following therapies in a bid to determine if one or multiple drugs can help reduce the severity of the virus.
TrialSite has reported on a major Colchicine study, such as the decentralized Colcorona study. UT Southwestern represents a trial site for a study to investigate whether the drug used for gout can decrease the incidence of the hyperimmune reaction observed in some COVID-19 patients. This study uses a pill form of the drug and involves no blood drawing or nasal swabs. Those interested in participating must be at least 40 years of age and have at least one risk factor (e.g. diabetes, high blood pressure or obesity). The participating patient must have just started experiencing COVID-19 symptoms within a week or less and have in possession a positive nasal swab within the last 48 hours.
The academic medical center is also investigating monoclonal antibodies involving a single intravenous infusion coupled with nasal swabs over a two week period. The research team seeks to identify if the virus clears any faster. In this study, participants must have had symptoms for less than a week. Again, the goal is to catch and treat the disease early.
This is the only approved drug by the U.S. Food and Drug Administration (FDA) for COVID-19. Still in the emergency use category, Gilead has filed its new drug application for commercialization. The drug can only be used for patients in the hospital so that currently limits its use for more early stage use. Moreover, the drug must be administered via intravenous injection.
Participants in this study must be 60 or between 18 and 60 with one or more risk factors (e.g. hypertension, cardiovascular, etc.).
TrialSite has covered this interesting antiviral perhaps more than other media. Approved in Russia, China and India to treat COVID-19, the drug is also approved in Japan, its place of origin, for influenza. The U.S. The Department of Defense (DOD) invested heavily (over $200 million) in favipiravir to consider targeting pathogens such as coronavirus. At the time, the government partnered with a company called MediVector. The executive in that company founded Appili Therapeutics, which is trying to commercialize favipiravir. With a trade name of Avigan, the drug is now deemed generic.
UT Southwestern has a study where favipiravir is taken orally again unlike remdesivir, which requires intravenous administration. Patients need to be sick with COVID-19 for less than a week and show proof of positive nasal swab within the past 72 hours.
Call to Action: If you are based in the Dallas-Fort Worth metroplex and interested in these studies, contact UT Southwestern at 214-648-7494.