New COVID-19 outpatient treatments including pill, injection and inhaled medicine part of clinical trial at KU Medical Center
February 11, 2021
By Kay Hawes
Three new outpatient treatments will be tested at the University of Kansas Medical Center in efforts to broaden options for COVID-19 patients. These new treatments may make it easier to receive COVID-19 treatment outside a hospital, as they include:
- an oral pill
- an injection
- a medication that can be inhaled through a home nebulizer.
"It's critically important that we develop COVID treatments that lessen the impact of the disease while reducing the time and effort taken to implement them," said 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. "Even as more people are vaccinated, we must continue to find ways to shorten the duration and severity of the disease for those who get COVID."
Call for potential participants
This new trial is open to most adults who have a positive COVID-19 test. There's no need to have a pre-existing condition or meet a certain age limit.
Understanding the science behind the treatments
What are monoclonal antibodies?
"Monoclonal" refers to an antibody manufactured in a laboratory. Monoclonal antibodies may block a protein associated with the virus and then neutralizes the virus itself. Monoclonal antibodies are known to be safe and are already used treat other diseases, such as asthma or rheumatoid arthritis.
What are interferons?
Interferons are a family of signaling proteins that are called that because they will interfere with viruses and help the immune system fight them off. Interferons are already used to treat other diseases, such as multiple sclerosis and cancer.
What are enzyme inhibitors?
Enzyme inhibitors stop or slow down virus replication by binding to an enzyme and hampering its function. Many antibiotics are enzyme inhibitors, and enzyme inhibitors also are used in chemotherapy to treat cancer.
Castro explained that trial participants will be randomly placed in one of three different arms of the trial:
- Delivery of a monoclonal antibody by injection versus the more time-consuming intravenous drip.
- Inhalation of interferon that patients can inhale directly into their lungs through a nebulizer. (This is method that many asthma and COPD patients already use for their medicines.)
- A pill taken orally four times per day. The pill is an enzyme inhibitor that may hamper the ability of the virus to reproduce.
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.
Another trial under ACTIV-2
All of the drugs are being tested as part of a unique nationwide clinical trial known as Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-2), which allows multiple drugs to be tested under the same trial protocol, saving time and effort.
"We are in a crisis, in a pandemic, and we are working with a limited repertoire of treatments," Castro said. "Right now, monoclonal antibodies are the only effective outpatient treatment option against COVID," Castro said. "This study design enables us to quickly add new drugs and examine new treatment types while using the same sites and the same staff."
KU Medical Center is one of at least 95 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.