When Christina Loville developed a headache at work one afternoon, she did not think too much of it. However, as the day wore on and she began to feel achy and lost her sense of smell and taste, she knew something was wrong. Just to be safe, Loville immediately left work to be tested for the coronavirus. When her results came back, she was terrified. She had COVID-19.
“I was so scared the night I found out. I honestly thought I was going to die. I started setting up my living will because I did not know what to expect or if the statistics on who gets better and who doesn’t would be in my favor,” Loville said. She decided to channel her fear into researching COVID-19 treatments, where she discovered the ACTIV-2 trial. She reached out and was referred to the local study site, led by experts at The University of Texas Health Science Center at Houston (UTHealth).
The Phase II, randomized, blinded, controlled, adaptive platform trial is enrolling patients at Harris Health System’s Lyndon B. Johnson Hospital. Roberto C. Arduino, MD, professor of infectious disease with McGovern Medical School at UTHealth, serves as the principal investigator for this site. The research team is studying the effectiveness of multiple treatments, such as laboratory-produced antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting.
Adaptive clinical trials observe patient outcomes and any side effects that occur during the trial. They also allow for modifications based on those observations and for introduction of new medications during the trial. This trial will study various medications as they are developed, allowing researchers to effectively test them against a placebo.
The first treatment being tested, for which Loville was randomized, is LY-CoV555, a monoclonal antibody developed from the blood sample of a recovered COVID-19 patient.
While Loville doesn’t know if she received the treatment agent or a placebo, she does know she feels much better. “There were bad days when I first got sick, days where I really felt like I would never get over this. In less than a week since I’ve had the infusion, I already feel so much better. I finally see the light at the end of this tunnel,” she said.
According to Netanya S. Utay, MD, a study co-investigator and an associate professor of internal medicine at McGovern Medical School, being able to compare a treatment agent such as LY-CoV555 to a placebo in a clinical trial is crucial to finding effective therapies and a cure for COVID-19, the illness caused by SARS-CoV-2.
“If we give a patient a treatment agent outside of a trial setting, we don’t know whether the person recovered because they were going to get better regardless, or if the drug was responsible,” Utay said. “We also don’t know if the agent helped them get better faster than they would have otherwise.”
Loville’s next steps as trial participant include keeping a symptom diary and collecting nasal swabs to monitor the amount of SARS-CoV-2 in her nose. She will also have a series of five more in-person visits with the trial research team to monitor her symptoms and test her blood to see how the treatment is affecting viral shedding and whether there are other reactions. This will help determine if the monoclonal antibodies can reduce or stop transmission of SARS-CoV-2.
At a time when all eyes are fixed on research efforts searching for safe and effective COVID-19 treatments, Utay said it’s critically important for people to enroll in the available clinical trials.
“We know more now about treating COVID-19 than we did in March and April, thanks to some studies that have already been done. However, we still have very few tools to treat people with this illness,” Utay said. “We don’t have any treatment to offer to outpatients to decrease their chances of being hospitalized. Some patients suffering from the virus are hospitalized for weeks and even months. An arsenal of proven treatments for COVID-19 would save lives, prevent prolonged illness, and get people healthier sooner so they can go back to living their lives.”
Loville expressed how grateful she was to participate in the search for a COVID-19 treatment.
“I am blessed to be part of something that I believe not only helped me get better, but will hopefully help many more people too,” she said.
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