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Two new monoclonal antibody outpatient treatments for COVID-19 target older people and those with additional medical conditions

January 12, 2021

By Kay Hawes

Gloved hand holding clear vial marked "monoclonal antibodies"
The University of Kansas Medical Center will be part of a multisite clinical trial testing two different types of monoclonal antibodies used for combatting the SARS-CoV-2 virus. Participants must meet criteria and be within 10 days of the onset of COVID-19 symptoms.

Two new monoclonal antibody treatments for outpatients with COVID-19 are being tested at the University of Kansas Medical Center. Known as BRII 196 and 198 and produced by Brii Biosciences, these investigational treatments are both monoclonal antibodies designed to block the ACE receptor, the protein that enables the virus to enter human cells, in the SARS-CoV-2 virus. Participants must have a recent diagnosis of COVID-19 and either be 60 years of age or older or have additional medical conditions.

Mario Castro, M.D., MPH, vice chair for clinical and translational research in the Department of Internal Medicine and a pulmonologist at the University of Kansas School of Medicine, will serve as principal investigator for the KU Medical Center site.

Who may participate?

"The criteria for these trials are different than before as there's a need to focus more on high-risk individuals," Castro said. The trials are open to those over 60 or those under 60 who are smokers or who have obesity, high blood pressure, active cancer, chronic lung disease, kidney or liver disease, or who are immunocompromised due to chronic illness or cancer treatments.

Castro noted that it's important to try to decrease COVID-19 hospitalizations and symptoms, particularly in older people and in those with underlying conditions. "These treatments may represent an opportunity to block the progression of the disease, which for some people has serious side effects, including lung fibrosis, strokes, heart failure, profound fatigue and long-term neurological damage."

Not a replacement for vaccine

Photo of Dr. Castro

"Ultimately to beat this virus, we are going to need a cocktail of treatments..."

Mario Castro, M.D., MPH

Even though vaccinations have begun, Castro noted that vaccination won't take the place of other treatments any time soon.

"Ultimately to beat this virus, we are going to need a cocktail of treatments, much like with HIV-AIDS," he said. "It's going to be a long period of time before the vaccine can be given to the general public and we can establish herd immunity in our society. And none of the vaccines are 100% effective." Castro also noted that those who have received the vaccine could be asymptomatic carriers, as can those who have developed antibodies due to recent infection.

"You have to be very careful," Castro said. "Even if you cannot get the virus right now due to a recent infection or because you've had both doses of the vaccine, you can still be a carrier and infect others."

Antibody blocks virus protein

Both of these investigational treatments are monoclonal antibodies. "Monoclonal" refers to an antibody manufactured in a laboratory. Castro noted that this is a neutralizing antibody that completely blocks a protein associated with the virus and neutralizes the virus itself. "This monoclonal antibody has a similar mechanism of action as the Lily monoclonal antibody we tested previously but it has a different target," Castro said. "Monoclonal antibodies are known to be safe. As physicians, we use monoclonal antibodies every day to treat other diseases, such as asthma or rheumatoid arthritis."

These treatments will be tested as part of a unique nationwide clinical trial known as Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-2). Announced by the National Institutes of Health (NIH) this spring, ACTIV-2 is a unique public-private partnership that allows for the testing of multiple agents to fight COVID-19. "ACTIV-2 is a creative trial design that provides a platform to allow you to get started and to introduce different agents as they become available," Castro said. "New potential treatments can be added under the same trial protocol."

How to join the clinical trial

KU Medical Center aims to recruit participants into the study who are within 10 days of the onset of symptoms and within seven days of a positive test. Participants must be over 60 or if under 60 have additional medical conditions, noted above. Those with active symptoms can contact:

Luigi Boccardi, study coordinator

KU Medical Center is partnering with The University of Kansas Health System to recruit participants through its outpatient clinics and swab clinics as well.

KU Medical Center is one of at least 90 sites across the nation that will be participating in this clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

NIAID is the regulatory sponsor and holder of the investigational drug application to conduct the ACTIV-2 study. The trial is being funded by NIAID through "Operation Warp Speed," a partnership led by the U.S. Department of Health and Human Services to invest in and coordinate the development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines. For more information, see the NIH website.

Last modified: Jan 12, 2021