Nursing Homes Launch Coronavirus Prevention Study
The BLAZE-2 Phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infections in long-term care facility residents and staff has launched in the USA.
LY-CoV555 is a neutralizing antibody against the SARS-CoV-2 betacoronavirus that causes COVID-19 disease, announced Eli Lilly on August 3, 2020.
This is important news since about 40 percent of COVID-19 disease-related fatalities have been linked to long-term care facilities in the US states of New Jersey, New York, and Pennsylvania during 2020.
The Lilly-sponsored BLAZE-2 study is a first-of-its-kind COVID-19 trial and is being conducted in partnership with NIAID, part of the National Institutes of Health (NIH), along with the COVID-19 Prevention Network (CoVPN) and several long-term care facility networks across the USA.
The BLAZE-2 study will enroll about 2,400 residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who are now at a high risk of exposure. It will evaluate 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 disease through 8 weeks.
To address the challenging aspects of running a clinical trial in a long-term care facility during a pandemic, Lilly created customized mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle to support mobile labs and clinical trial material preparation, along with a trailer truck that will deliver all clinical trial supplies needed to create an on-site infusion clinic.
To further minimize the burden on these facilities that normally do not conduct clinical trials, additional staff will be at the facilities to assist with the operations of the study. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the U.S.
"We commend Lilly and NIH in recognizing the critical need for developing medicines to combat the spread of the virus among some of the most vulnerable populations," said Dr. Alexander Stemer, an infectious disease expert and co-chair of Symphony Care Network's COVID-19 task force. "As the scientific community searches for safe and effective therapies for COVID-19, we are proud to participate in this leading-edge study given its potential to save lives."
On June 4, 2020, the US Centers for Medicare & Medicaid Services posted its first set of federal COVID-19 nursing home data on a new website.
Elaine Ryan, AARP vice president for state advocacy and strategy integration, stated in a press release published on June 11, 2020, ‘There’s a serious problem in these facilities and we need to know where the outbreaks are so we can target additional resources to help save lives.”
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and tested by the scientists at the NIAID Vaccine Research Center.
It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed the dosing of LY-CoV555 in a Phase 1 study of hospitalized patients with COVID-19 and long-term follow-up is ongoing.
BLAZE-1, a Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting, is ongoing. Based on current trends, enrollment is estimated to be completed in September, with initial data readout soon thereafter followed by full data in Q4’20.
LY-CoV555 has been well tolerated at all doses tested and no drug-related severe adverse events (SAEs) have been observed to date. Efficacy data are not yet available.
Lilly is committed to the rapid release of important scientific data. Large-scale manufacturing of this potential therapy continues, with the goal of having more than 1 hundred thousand doses available by the end of 2020, should LY-CoV555 prove to be a meaningful therapeutic option for COVID-19.
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Coronavirus therapeutic development news is published by Precision Vaccinations.