Although COVID-19 vaccines are now available for emergency use, that doesn’t preclude the desperate need for compelling, effective and safe therapeutics that can treat COVID-19. A range of pharmaceutical companies, from Merck and AstraZeneca to Lilly and Regeneron, continue to investigate various investigational products to broaden and deepen the available treatments. Ideally, new treatments will be not only easier to administer (e.g. orally available) but also available for ambulatory or home care. Leading academic medical center trial sites, such as the University of Kansas Medical Center (KU Medical Center) continue to lead and conduct major clinical trials investigating new outpatient options in this effort to broaden COVID-19 treatment availability. Part of the National Institutes of Health (NIH) sponsored Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, KU Medical Center is one of 95 trial site locations participating in ACTIV-2, supporting the study of multiple drugs under one master protocol in a move to save time and effort. Focusing on outpatient care, the investigational therapies include an oral pill, an injection and novel therapy consumed via a home nebulizer. KU Medical Center has partnered with the University of Kansas Health System for more robust patient recruitment via outpatient and COVID-19 test clinics.
KU Medical Center Understands Critical Need
Mario Castro, MD, MPH, serves KU Medical Center as vice chair for clinical and translational research in the Department of Internal Medicine and practices as a pulmonologist at the University of Kansas School of Medicine reports local media the Derby Informer. Given the importance of treating this disease early, and the fact that to date there are no approved drugs (or even drugs authorized under FDA emergency use authorization) for early onset mild cases, professor Castro reports, “It’s critically important that we develop COVID-19 treatments that lessen the impact of the disease while reducing the time and effort taken to implement them.”
Importantly, many in the community believe that with vaccines comes the end of the need for therapies. Of course, this is in fact far from the truth. Many people in America may not opt for receiving the vaccine, for whatever reason. Moreover, some people won’t be able to be inoculated due to certain risks. And others may find that they are the unlucky ones where the vaccine actually didn’t stop the virus. And with mutant SARS-CoV-2 strains spreading in America, the vaccines may in fact need to be continuously updated until the science of overcoming the coronavirus is better understood. Either way, Castro continued, “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-19.”
‘Limited Repertoire’ of treatments
Professor Castro further elaborated that making matters more difficult is the fact in the middle of this crisis that “…we are working with a limited repertoire of treatments.” He continued, “Right now, monoclonal antibodies are the only effective outpatient treatment option against COVID-19.” Moreover, the vice chair for clinical and translational research went on to say “This study design enables us to quickly add new drugs and examine new treatment types while using the same sites and the same staff.”
As TrialSite recently communicated, the ACTIV-2 master protocol, designed as a Phase 2 study can expand to Phase 3 seamlessly should the study drugs show efficacy. Tested in a population not hospitalized for COVID-19, the goal of this group of studies is to reduce the duration of symptoms and to test if the treatment can increase the proportion of participants with undetectable virus. The investigational therapies involved include Lilly’s LY-CoV555 (recently approved under emergency authorization known as Bamlanivimab as well as monoclonal antibodies from Brii Biosciences headquartered in China and Research Triangle in North Carolina. Also under investigation is a promising long-acting monoclonal antibody cocktail originally invented at Vanderbilt and licensed by AstraZeneca known as AZD7442 and finally an inhalable beta interferon investigational product from Synairgen. Inhalable and delivered via a nebulizer, the candidate is known as SNG001. Finally, the ACTIV-2 program also includes an orally administered serine protease inhibitor developed by Sagent Pharmaceuticals called Camostat mesilate. The NIH sought to test if this drug can block SARS-CoV-2 from entering the human cells.
Importantly, this study at KU Medical Center is open to most adults who have been tested as positive for COVID-19.
KU Medical Center Study Participation
Those in this region seeking to participate need to be within 10 days of the onset of symptoms and within seven days of a positive SARS-CoV-2 test. Luigi Boccardi, study coordinator, is the primary contact for this study and can be reached at 913-588-4022.