Our elderly have been devastated by SARS-CoV-2, the virus behind COVID-19, and this represents an unacceptable loss of lives for parents and grandparents. The death rates have been unacceptable and finally there’s an intensification of effort by Big Pharma and the NIH to do something about it. The TrialSite applauds an aggressive investment by Eli Lilly (Lilly) and the National Institute of Allergy and Infectious Diseases (NIAID) to collaborate and aggressively counter the horrific death rates occurring at long-term care (LTC) facilities. This major Phase 3 clinical trial includes a fleet of customized mobile units to support LTC facilities around the country. The investigational product could be a game changer. The TrialSite has reported on the world’s first antibody therapy targeting COVID-19. Found via a platform developed by a brilliant group out of University of British Columbia (UBC), which spun off the technology (AbCellera), Lilly scientists in an impressive show of commitment, dedication and intensity, cranked through and identified what is now known as LY-CoV555 in just a few months. While an ongoing Phase 2 trial commences, a Phase 3 clinical trial is announced for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the United States (e.g. skilled nursing facilities). The lead antibody identified in the Lilly and AbCellera collaboration, LY-CoV555, is a neutralizing antibody targeting SARS-CoV-2. Our elderly have been infected, and are dying at horrendous rates and the effort by Lilly and NIAID to intervene, invest and work to cut what has become an unacceptable death rate is applauded. There is an urgent need now to intervene and protect the elderly.
Although the Phase 2 study is not complete yet, the urgency of the matter combined with what undoubtedly are positive data points in Phase 1 and 2 studies has led the way to this Phase 3 study not yet disclosed in Clinicaltrials.gov. The Lilly-sponsored BLAZE-2 study is the first-of-its-kind COVID-19 trial and is conducted in collaboration with NIAID along with the reorganized and consolidated network of infectious disease government and academic medical center trial sites known as the COVID-19 Prevention Network.
The study will enroll patients and residents who are now at high risk of exposure at long term care facilities. It will evaluate the efficacy and safety of the investigational product for the prevention of SARS-CoV-2 infection and COVID-19, testing whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through 4 weeks, as well as complications of COVID-19 through 8 weeks. The sponsors seek to enroll up to 2,400 participants.
The TrialSite notes that based on at least a cursory review there are no published reports as to Phase 1 results of LY-CoV555. That Phase 1 study is scheduled to close August 23. Involving 40 participants to primarily assess the safety the TrialSite makes the assumption that the study is going well otherwise NIAID and Lilly would pursue such an aggressive Phase 3 undertaking so fast with such a vulnerable population.
Flexibility to Deal with the Circumstances
Lilly has created customized mobile research units to support the on-site study in order to address the challenging aspects of conducting a clinical trial in a long-term care facility during a pandemic. The units include custom retrofitted recreational vehicles (RV) to support mobile labs and clinical trial material preparation, in addition to a trailer truck that helps deliver clinical trials supplies required to create an on-site infusion clinic. These mobile research units will be deployed across America to combat the virus in long-term care facilities. The study will invest to add additional human resources to help conduct these studies as often long term care facilities don’t have sufficient staff capacity for major clinical trials.
Urgent Need for Intervention in Long-Term Care Facilities
The TrialSite recommends researchers and clinicians consider additional treatment options as well, even looking abroad to consider what types of treatments are helping to at least potentially slow down COVID-19. The situation is urgent especially with high risk, vulnerable populations. Check in with the TrialSite as analysts report on studies worldwide.
Call to Action: Clinical investigators, hospitals or clinical sites interested in participating in one of Lilly’s clinical trials for a potential COVID-19 treatment can call 1-877-285-4559 or email [email protected]. Patients interested in Lilly’s studies for a potential COVID-19 treatment can visit Lilly TrialGuide for information regarding eligibility for these ongoing studies.