KU Medical Center to participate in clinical trial designed to speed the testing of COVID-19 outpatient treatments
September 22, 2020
By Kay Hawes
The University of Kansas Medical Center will be participating in a unique nationwide clinical trial that will allow for the testing of multiple agents to fight COVID-19. Known as ACTIV-2 (Adapt Out COVID), this trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines effort announced by the National Institutes of Health (NIH) this spring.
Mario Castro, M.D., MPH, vice chair for clinical and translational research and a pulmonologist at the University of Kansas School of Medicine, will serve as principal investigator for the KU Medical Center site, along with co-investigator Leslie Spikes, M.D., assistant professor of pulmonary and critical care medicine at the KU School of Medicine. This trial will test treatments for participants currently infected with SARS-CoV-2 and experiencing mild-to-moderate COVID-19 that does not require hospitalization.
"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."
The first agent to be tested at KU Medical Center is a monoclonal antibody owned by Eli Lilly and Company, LY3819253, that will be given as a one-time dose intravenously. Antibodies are infection-fighting proteins produced by immune cells. This antibody was isolated from a blood sample from a recovered COVID-19 patient, then synthesized in a laboratory. "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 was developed to specifically target the spike protein in COVID-19," Castro said. "As physicians, we use monoclonal antibodies every day to treat other diseases, such as asthma or rheumatoid arthritis."
KU Medical Center is one of at least 40 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.
Need for outpatient treatments
It is critical to find treatments for outpatients, Castro notes, in part because there is no clinically proven outpatient treatment for SARS-CoV2. Remdesivir, which has shown benefit to hospitalized patients and has been authorized by the FDA for emergency use for inpatients, must be given intravenously and is not suitable for outpatients.
"This monoclonal antibody was developed to specifically target the spike protein in COVID-19."
Mario Castro, M.D., MPH
Co-investigator Spikes explains that outpatient treatment options for COVID-19 are critical to lessening hospitalizations. "This is a very important trial to help us find outpatient treatments for COVID-positive patients to hopefully prevent further hospitalizations, long-term complications and deaths from this devastating disease," Spikes said.
Castro notes that the purpose of this phase 2/3 trial is to reduce symptoms and length of illness. "Once you get sick from this coronavirus, there are lingering effects from weeks to months," he said. "If we could have a therapy that could lessen the length of that illness, it would be very powerful."
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. Those with active symptoms can contact the study coordinator, Luigi Boccardi, at 913-588-4022. KU Medical Center is partnering with The University of Kansas Health System to recruit participants through its outpatient clinics and swab clinics as well.
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.
The clinical trial is one of four ongoing or planned trials in NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership and initiative to speed development of the most promising treatments and vaccine candidates. For more information, see the NIH website.