BLAZE-1 study evaluating safety, effectiveness of potential antibody treatment
INDIANAPOLIS, Indiana | Franciscan Health Indianapolis has begun recruiting and treating patients in a clinical research study to evaluate the safety and effectiveness of an antibody treatment drug, LY-CoV555, in patients with early mild to moderate COVID-19 illness caused by a coronavirus called SARS-CoV-2.
Sponsored by Eli Lilly and Company, the BLAZE-1 Study is looking for adults ages 18 and older who have recently tested positive for COVID-19 and are not hospitalized.
Franciscan Health Hammond has also been designated as a research site for the BLAZE-1 study and will soon be recruiting patients as well.
“Kicking off the BLAZE-1 Study with research sites around the country, including Franciscan Health, is a huge milestone for the global fight against COVID-19, and we’re excited to bring the industry one step closer to a potential treatment,” said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. “We look forward to working with eligible patients who are not only interested in receiving investigational treatments for COVID-19, but who also understand how their participation can impact the health and well-being of millions of people around the world.”
LY-CoV555 is an antibody therapy engineered from one of the first individuals in the U.S. to recover from COVID-19 and is specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. Laboratory studies have shown that LY-CoV555 binds with high affinity to the SARS-CoV-2 virus and neutralizes its ability to infect cells and replicate.
“Franciscan Health Indianapolis has treated hundreds of patients with COVID-19 and provided testing for more than 11,000 residents,” said Imad Shawa, MD, pulmonary critical care specialist and principal investigator for the Franciscan’s study site. “We’re pleased to be chosen by Lilly to participate in this important research for a treatment that may help curb the spread of the coronavirus.”
To be eligible for the BLAZE-1 Study, participants must have tested positive for SARS-CoV-2 infection within three days prior to the study drug infusion and have one or more mild or moderate COVID-19 symptoms, including, fever, cough, sore throat, headache, muscle pain, nausea, abdominal pain, diarrhea, or shortness of breath when active.
If a person is eligible and decides to participate, Franciscan Health’s research staff will perform specific tests and procedures to monitor the patient’s health and how their body
reacts to the LY-CoV555 antibody treatment. These tests and procedures include physical exams, vital sign measurements, blood samples and nasopharyngeal swabs to measure levels of virus.
The study drug is being compared to a placebo, and both the study drug and the placebo will be administered as a single-dose intravenous infusion. Participants will be randomly selected to receive the placebo or the study drug.
Franciscan Health Indianapolis and Hammond are two of 24 hospitals across the country chosen to be research sites, and two of three in Indiana.
If you have tested positive and exhibited symptoms for COVID-19 and wish to participate in this study, call (833) 277-0197 or visit JoinCOVIDStudy.com to learn more.