Two new COVID-19 treatment trials hope to prevent disease in people who have been recently exposed to the virus and allow others who have been recently infected to avoid serious symptoms. Dallas’ Southwest Family Medicine Associates (SFMA) is one of 33 sites in the country to host these trials.
For months, those infected with COVID-19 were either recovering on their own or receiving treatment at a hospital. When patients didn’t respond to the standard antiviral medicines, their treatment was upgraded. Today, patients can receive an infusion of monoclonal antibodies, a synthetic version of the antibodies that exist in those who have recovered from COVID-19. To use blood-borne antibodies, a patient has to wait for a donor with their matching blood type, but the synthetic version can be applied to anyone. This treatment is effective, but it is expensive, time-consuming (four hours long), and often limited because it requires an infusion.
The new trial uses those same monoclonal antibodies but will administer the treatment through an intermuscular shot given in an outpatient clinic. The therapy is being used in two different ways. SFMA is looking for patients who have recently tested positive (the clinic is offering free testing), so antibodies may be administered to prevent severe symptoms. Additionally, if a person has recently been exposed to someone who has COVID-19, the antibodies can be administered to prevent infection.
Dr. Chrisette Dharma, the medical director at SFMA, compares this treatment to receiving routine medicine after strep throat or another similar infection. “I’m super excited about using it like an antibiotic,” she said. “There’s infection all the time everywhere, and we’re not scared; we’re not terrified.”
Dharma has seen the problems that current COVID treatments’ limited accessibility present first hand. Her brother ended up in the hospital with COVID-19 and wasn’t responding to Remdesivir or other treatments. Using her connections, she was able to get him a monoclonal antibody infusion, and he eventually recovered. But not everyone has those resources. “There is such a difference when you know the system, and you can manipulate the system to your advantage,” she said.
But why would we need this treatment if vaccinations continue to progress? Dharma compared it to treatment for the flu: We have a flu shot given every year, but there are also treatments for the flu. This trial is about replicating that process for COVID-19. No one is sure how long the vaccines will last and if boosters will be required. If the vaccine wears off and someone is infected, this new treatment could prevent severe symptoms. Also, new variants are more contagious and more resistant to the current vaccines. If those variants continue to spread, this shot can be used to treat those who become infected, just like someone might receive a steroid or penicillin for an infection.
Additionally, the pandemic shut down much of society to prevent hospital overcrowding and reduce the number of deaths. This treatment could achieve both of those goals. Effective, accessible, and affordable treatment is key to returning our lives to a pre-pandemic normal. If the FDA approves this treatment, we may be on our way. “There’s still going to be COVID, and I don’t think that’s ever going to go away,” Dharma says. “I think there will be the need to treat it early and not let it inhibit our lives. We’re still going to need a treatment that is fast, easy, efficient, and doesn’t have a lot of barriers.”
The trial is in phase III and is looking for 1,000 patients nationwide to confirm that the drug is as effective as it has been in previous stages. Dharma says the trial will probably only last a month and will be given emergency-use authorization by the FDA soon after.
SFMA is no stranger to medical trials and has been involved with a number of them over the last 15 years, which is pretty rare for a community clinic. The clinic is looking to enlist diverse adult patients who have recently tested positive (within ten days) or been recently exposed to COVID-19, and patients are paid for their time. The testing and treatment are free.
Call 469-893-1242, or visit dallascovidtrials.com to learn more.