Lilly partners with UnitedHealth Group for pragmatic study of bamlanivimab in high-risk COVID-19 patients

Eli Lilly and Company (Lilly) has formed a strategic collaboration with UnitedHealth Group to conduct a pragmatic clinical study on bamlanivimab (LY-CoV555), a monoclonal antibody treatment for COVID-19. This partnership aims to evaluate the effectiveness of bamlanivimab in real-world settings, focusing on individuals at high risk for severe illness from COVID-19. The study will examine the treatment’s safety and efficacy in individuals meeting the criteria set forth by the U.S. Food and Drug Administration’s emergency use authorization (EUA).

Bamlanivimab, which recently received EUA from the FDA, has been authorized for use in patients with mild to moderate symptoms who are at high risk of developing more severe illness or requiring hospitalization. The clinical trial, a collaboration between Lilly and UnitedHealth Group, will leverage UnitedHealth’s expansive healthcare resources, including its UnitedHealthcare and Optum health services arms. These divisions will play a pivotal role in identifying, tracking, and treating patients who meet the eligibility requirements for bamlanivimab administration.

The study will be conducted under real-world conditions, allowing the researchers to assess how bamlanivimab performs outside of controlled clinical trial environments. According to Eli Lilly, the aim is to treat a broad and diverse group of high-risk COVID-19 patients with the antibody therapy, hoping to reduce the severity of the disease and lower hospitalizations.

UnitedHealth Group will provide significant support through its Optum health services, including daily symptom monitoring, in-home SARS-CoV-2 testing, and home-based infusion services for patients. This approach is designed to allow patients to remain isolated at home, minimizing the potential spread of COVID-19 while receiving treatment.

Lilly’s Chief Scientific Officer, Daniel Skovronsky, emphasized the importance of conducting larger, more diverse studies in real-world settings to further understand the long-term effects and efficacy of SARS-CoV-2 neutralizing antibodies. He noted, “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.”

The partnership will also include OptumLabs, UnitedHealth Group’s research division, which will contribute to the design and execution of the study. Ken Ehlert, Chief Scientific Officer of UnitedHealth Group and CEO of OptumLabs, pointed out the critical role treatments like bamlanivimab play in the fight against COVID-19. “Intercepting the disease before it escalates may help to keep people out of the hospital and reduce the overwhelming burden on the healthcare system,” he stated. Ehlert also noted that by combining UnitedHealth Group’s expertise in clinical research and technology with Lilly’s pharmaceutical development, the two companies aim to expedite the research process for this promising COVID-19 treatment.

The study will target members of UnitedHealthcare’s Medicare Advantage program who meet the FDA criteria for bamlanivimab treatment. These individuals will be invited to participate through United in Research, the company’s virtual community platform designed to engage “citizen scientists” in clinical research.

As the COVID-19 pandemic continues to strain healthcare systems globally, the collaboration between Eli Lilly and UnitedHealth Group holds the potential to provide crucial insights into how monoclonal antibody treatments like bamlanivimab could help mitigate the impact of the virus on high-risk populations. If successful, the study could pave the way for broader adoption of such treatments, reducing hospitalizations and improving outcomes for patients suffering from the virus.