Lilly and UnitedHealth Group partner on pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19

Eli Lilly and Company and UnitedHealth Group announced a partnership to conduct a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals.

Bamlanivimab recently received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. The trial will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in individuals that meet the EUA criteria.

The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations. It will draw upon both UnitedHealth Group’s UnitedHealthcare health benefits business as well as its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.

Delivering bamlanivimab to patients through home infusions allows them to stay quarantined and at home, minimizing the potential spread of COVID-19.

“While bamlanivimab is authorized for emergency use based on the efficacy and safety data accumulated to date, larger pragmatic studies in diverse populations can help us further understand the efficacy and safety of SARS-CoV-2 neutralizing antibodies in real world settings,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “Lilly is excited to partner with UnitedHealth Group to study our antibody therapy using a care delivery model that will allow rapid diagnosis and in-home treatment of patients at a high risk of complications.”

Under the study design, UnitedHealthcare Medicare Advantage members who meet the FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, a UnitedHealth Group virtual community and technology platform for citizen scientists.

Those who volunteer and are in an area where they can receive treatment will be directed to download Optum’s symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab. The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy.

“Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available,” said Ken Ehlert, chief scientific officer, UnitedHealth Group and chief executive officer, OptumLabs. “Intercepting the disease before it escalates may help to keep people out of the hospital and reduce the overwhelming burden on the healthcare system. By bringing together UnitedHealth Group’s expertise in science, clinical research, and technology, with Lilly’s expertise in pharmaceutical development, we can responsibly and safely accelerate research on this new potential COVID-19 treatment.”

This study is part of a collaborative partnership between OptumLabs, the scientific research arm of UnitedHealth Group, and Lilly to advance cutting-edge science, research, and solutions that will accelerate the progression of validated therapies into real world applications.