Landmark Trial to Recruit Adults Who Recently Tested Positive for COVID-19
Cook County Health is one of only 24 hospitals in the U.S. to test the safety and efficacy of a possible antibody treatment drug that may help patients with mild to moderate COVID-19.
Called the BLAZE-1 study, the trial will evaluate the antibody known as LY-CoV555, which was derived from one of the first U.S. patients to survive COVID-19.
Study participants in the randomized, placebo-controlled trial will be given a one-time intravenous infusion of the medication LY-CoV555.
Antibodies have been proven to be effective to fight viruses, bacteria and other foreign substances. Specifically, antibody medications that have been approved by the U.S. Food and Drug Administration can effectively treat cancers, autoimmune disorders and other infectious diseases.
“It is important to evaluate therapies that use technology to mirror our own immune system’s ability to disarm potential damaging effects of viral infections to prevent serious complications we’ve seen during this COVID-19 pandemic,” said Dr. Gregory Huhn, an infectious disease physician for Cook County Health and principal site investigator of the BLAZE-1 study. “Our hope is that the antibody drug will reduce COVID symptoms quickly after diagnosis and help to eradicate the virus more quickly.”
To be eligible to participate, patients must be 18 years or older, have tested positive for the SARS-CoV-2 infection within three days prior to the study drug infusion and are experiencing one or more mild to moderate COVID-19 symptoms such as fever, cough, sore throat, malaise (not feeling well), headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. Participants must not have other serious medical conditions and exhibit evidence of infection in the lungs with a certain level of oxygen in the blood.
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 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.
Study participants will be followed for approximately 12 weeks following the initial administration of either the antibody medicine or a placebo. Follow-ups will be performed at home or by phone.
If a person is eligible for the BLAZE-1 study and decides to participate, the research staff will perform specific tests and procedures to monitor the study participant’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.
For more information on the study, please visit JoinCOVIDStudy.com. To sign up for the trial at Cook County Health, call 312-864-4606.
Eli Lilly and Company, the maker of the antibody medicine LY-CoV555, is sponsoring the study.
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.