Recruiting Adults Who Recently Tested Positive for COVID-19 for Clinical Trial

Eli Lilly and Holy Cross Health Research Institutes Begin Recruiting Adults Who Recently Tested Positive for COVID-19 for Clinical Trial

Holy Cross Health along with Principal Investigator Joshua Purow, MD, announced it has begun recruiting and treating patients in a clinical research study to evaluate the safety and effectiveness of an antibody treatment drug, LY3819253, 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.

To be eligible for the study, patients 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, malaise (not feeling well), headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.

“We are learning more about COVID-19 every day, and we’ve identified antibody treatment as a promising path forward to neutralizing this virus,” said Dr. Daniel Skovronsky, chief scientific officer, Eli Lilly and Company. “Kicking off the BLAZE-1 Study with research sites around the country, including Holy Cross Health, is a huge milestone for the global fight against COVID-19, and we’re eager to bring the industry one step closer to a potential treatment.”

If a person is eligible for the BLAZE-1 Study and decides to participate, the research staff at Holy Cross Health will perform specific tests and procedures to monitor the study participant’s health and how their body reacts to the LY3819253 antibody treatment. These tests and procedures include physical exams, vital sign measurements, blood samples, and nasopharyngeal swabs.

“Holy Cross Health has been on the front lines of the fight against COVID-19, and we are honored to participate in this important landmark study with Lilly to potentially bring effective COVID-19 treatment to the public faster,” said Mark Doyle, President and CEO, Holy Cross Health.

Eli Lilly and Company is partnering with AbCellera Biologics Inc. to develop antibodies as a potential treatment for COVID-19, and Lilly will use AbCellera’s core platform screening technologies to select a candidate’s antibody gene sequences from a recently recovered COVID-19 patient’s serum. Lilly plans to develop antibodies that will prevent subsequent viral entry into human cells and viral replication, which is expected to mitigate the severity of the disease in some patients. The decrease in viral replication may also shorten a patient’s extent and duration of viral shedding and transmission, positively impacting public health.

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 (IV) infusion. Participants will be randomly selected to receive the placebo or one of three doses of the study drug (700 mg, 2,800 mg, or 7,000 mg). An optional fourth dose may also be added.

The efficient community spread of SARS-CoV-2 has resulted in the current pandemic of COVID-19, which in severe and critical cases results in progressive pulmonary infection, complicated by respiratory failure, with a high prevalence of acute respiratory distress syndrome and can result in death. Although several therapies have been explored in severe COVID-19, including antivirals, glucocorticoids, and immunoglobulins, none have been shown to improve survival.

If someone has tested positive and exhibited symptoms for COVID-19, and is interested in participating in clinical research in their area, call 833.277.0197 or visit JoinCOVIDStudy.com to learn more.

About Lilly’s COVID-19 Efforts


Lilly is bringing the full force of its scientific and medical expertise to attack COVID-19 around the world. We’re fighting the pandemic in every way we can: discovering potential medicines to treat and prevent COVID-19, maintaining a reliable supply of our medicines, and supporting patients and communities in times of need. Lilly is studying multiple approaches to treat COVID-19, including existing Lilly medicines to understand their potential in treating complications of COVID-19 and potential antibodies specifically designed to attack the virus.

About Eli Lilly and Company


Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

About Holy Cross Health


A member of Trinity Health, Fort Lauderdale, FL-based Holy Cross Health is a full-service, non-profit, Catholic, teaching hospital operating in the spirit of the Sisters of Mercy. Holy Cross Hospital has been named one of the top hospitals in the Miami metro area in U.S. News and World Report's 2020-2021 Best Hospital rankings. Through strategic collaborations and a commitment to being a person-centered, transforming, healing presence, the 557-bed hospital offers progressive inpatient, outpatient and community outreach services and clinical research trials to serve as our community’s trusted health partner for life. To learn more about Holy Cross Hospital, visit holy-cross.com.

Lilly Cautionary Statement Regarding Forward-Looking Statements


This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about LY3819253 as a potential treatment for patients with COVID-19 and reflects Lilly’s current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that LY3819253 will prove to be effective in treating or preventing COVID-19. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. P-LLY