Avera Chosen as Clinical Site for Experimental Antibody TherapySep 01, 2020 12:58PM ● By MED Magazine
Avera will participate in three Phase 2 and 3 clinical studies evaluating whether a combination of two lab-made antibodies can not only treat, but prevent SARS-CoV-2, the virus that causes COVID-19.
The clinical studies are sponsored by Regeneron Pharmaceuticals, Inc., which was approved to move forward following positive Phase 1 safety results. Phases 2 and 3 will focus on testing the effectiveness of the drugs to either prevent or treat COVID-19. Avera is one of many sites enrolling people to study this experimental therapeutic option.
“COVID-19 has created two tremendous medical needs in the areas of treatment and prevention,” said Amy Elliott, PhD, Chief Clinical Research Officer of the Avera Center for Pediatric and Community Research. “That’s why we’ve chosen to participate in these trials – we’re not just looking at finding effective treatments, but also whether we can prevent people who have recently been exposed from getting sick.”
The clinical trials will focus on three different patient groups:
- People hospitalized with COVID-19, evaluating if it can stop progression of the disease
- People diagnosed with COVID-19 but not hospitalized, evaluating if the combination of antibodies can stop progression of the disease
- People who were exposed to someone with COVID-19, evaluating if it will decrease symptom severity or even prevent the disease altogether
“This is a really exciting opportunity to be at the forefront of research in this area,” said Jawad Nazir, MD, the principal investigator for the three studies and an infectious disease specialist with Avera Medical Group. “One of the reasons we chose these studies is they examine various combinations of two different antibodies, designed to specifically target this disease and how it attacks cells.”
How it Works
An antibody is a protein. During infection the body produces several types of antibodies. These antibodies can recognize viruses as foreign invaders by binding to parts of the virus. When this happens, it can block entry into a person’s cells. This can be critical to preventing disease, but it can also prevent a virus from progressing further.
The Regeneron trials use monoclonal antibodies, which are created in a lab. These two antibodies are designed to bind to two different points on the SARS-COV-2 spike protein. Spike proteins are the pointy parts that stick out of the SARS-CoV 2 virus. The monoclonal antibodies being tested in these studies block the spike protein from attaching to host cells, thereby keeping the virus from infecting those cells. By lowering the ability of the virus to infect cells, the study drug may help to stop COVID-19 symptoms from getting worse and even preventing it from developing after people are exposed.
“We know the antibody plays a role in neutralizing infection; the concept of these trials is to test this ability as an option for COVID-19,” said John Lee, MD, Clinical Medical Officer for Cancer Research at Avera Cancer Institute. “In a pandemic situation, if we can find a potential therapy that can also decrease the spread of the disease or make the infection less severe, that’s really ideal and that’s what’s unique to these studies.”
Dr. Nazir will play a leading support role, Dr. Lee will play a supportive clinical role, while Dr. Elliott and her clinical research team will lead the operational elements. The study requires involvement from many areas within Avera, including [email protected], the Infusion Center, pharmacy, labs and testing sites.
Eligible participants must be 18 years or older and live in the Sioux Falls area. Call 605-504-3154 if you think you or a family member may meet the criteria for one of these studies.