UAB begins clinical trial of COVID drug given to Trump

UAB Hospital is recruiting patients for clinical trials of new antibody treatments for COVID-19, including the Regeneron treatment administered to President Donald Trump last week.

The University of Alabama at Birmingham Hospital is helping to develop new techniques to combat the virus that has killed 210,000 Americans and 2,600 in Alabama. UAB is now testing the effectiveness of two new monoclonal antibody drugs and testing convalescent plasma, which is donated from people who have recovered from the virus.

“Our team is excited,” said Dr. Turner Overton, who is leading an outpatient trial for a monoclonal antibody treatment developed by Eli Lilly. “I’m really looking forward to being part of these studies to create a situation where we can have drugs to offer people in the outpatient setting and get our lives back to normal.”

The monoclonal antibody treatments target the spike proteins on the surface of the virus in an attempt to block the virus from entering human cells. This is done through monoclonal antibodies created in a lab or through convalescent plasma, which contains antibodies.

Trump received an infusion of a monoclonal antibody cocktail developed by drug-maker Regeneron over the weekend, according to his doctors.

Overton and Dr. Sonya Heath, both professors of medicine in UAB’s Division of Infectious Diseases, said these antibody treatments are most helpful when administered early on in the course of the disease, when the virus is still reproducing rapidly in an infected patient.

“If we can stop the virus in its tracks say in the first three or four days, then we can potentially block the consequences,” Overton said. “So, that’s exactly what we’re trying to do.”

Heath said the hospital is in the early phases of recruiting patients for the study on the Regeneron treatment, as well as a similar antibody drug developed by Eli Lilly, and convalescent plasma.

“This is an antibody-based trial where we are infusing people with a cocktail of antibodies,” Heath said. “You get a combination of two different antibodies targeting proteins on the surface of the virus, and if it can bind to the virus, it can help eliminate it and really reduce the severity of illness.”

Heath said the Regeneron study is looking to enroll 1,200 to 1,300 patients nationwide and that UAB might enroll 50 or more of those patients.

“We may have a goal of 25 or 50 patients within a trial, but oftentimes, if we are doing a good job enrolling and we have a lot of trial experience here at UAB so they get the data that they need for safety and efficacy, then they will allow us to enroll more people,” Heath said.

Overton said the Eli Lilly drug works much the same way as the more famous Regeneron treatment.

“This monoclonal antibody hasn’t gotten as much press [as Regeneron] because not as many famous people have received it, but it is a similar monoclonal antibody that has shown to be effective in the preliminary trials, the phase one and two trials, so that’s exciting,” he said.

One key difference is the Eli Lilly drug is an outpatient trial, and is being administered to COVID patients who are not hospitalized.

‘Proof of concept’ for vaccines

In addition to these studies, UAB is continuing to recruit volunteers for COVID vaccine trials.

While these antibody drugs are not vaccines, Overton said the fact that the SARS-CoV2 virus responds to antibody treatment bolsters the hope that vaccines in development might also be effective.

“It’s sort of a proof of concept for the vaccine studies that we have ongoing as well,” Overton said. “If antibodies are generated by vaccines, that’s one of the big ways that we get immunity from vaccines, and so if this passive immunization strategy works with either convalescent plasma and or with monoclonal antibodies, it really gives a lot of strength to pursuing effective vaccines.”

How to sign up

People interested in volunteering for the trials at UAB are urged to call 205-934-6777, where an operator will gather some information and determine whether they might qualify for one of the trials.

Overton said the studies were recruiting patients who have COVID and are hospitalized, people who have tested positive but are not hospitalized and patients who do not have COVID-19 for vaccine trials. He said they are also interested in recruiting patients who have recovered from COVID-19 and may be able to donate plasma for those treatments.

“We’re recruiting across the spectrum of disease,” Overton said. “Really anybody and everybody who is interested in volunteering for a research study could call about participation.”

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