Eli Lilly and Company (Lilly) has revealed plans to launch a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with Covid-19, in partnership with major local institutions in New Mexico.
The US pharma giant said that carrying out the study in New Mexico will help in the collection of data on the effectiveness and safety of the recombinant, neutralizing human IgG1 monoclonal antibody (mAb) in a real-world setting, which includes a diverse population, that is spread across rural and urban environments.
Last month, bamlanivimab was granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of mild to moderate Covid-19 patients, who are at high risk for progressing to severe infection and/or need hospitalization.
Daniel Skovronsky – Lilly chief scientific officer and president of Lilly Research Laboratories said: “It is important to continue building on the evidence base for bamlanivimab through ongoing studies, including those in a real-world setting.
“In addition to gathering treatment and safety data, Lilly will use this study to explore the delivery of bamlanivimab in a variety of innovative infusion settings, which could help inform best practices and ultimately replication by institutions around the country.”
The study will begin in the coming weeks and will evaluate the effectiveness of bamlanivimab in reducing COVID-19 hospitalizations in a high-risk population. Under the study design, a variety of infusion settings will be utilized across the state, allowing access to multiple diverse communities – including Native American communities.
Lilly, as part of the pragmatic study of bamlanivimab, will use its mobile research units, which include a customized retrofitted recreational vehicle (RV) solution for supporting mobile labs and clinical trial material preparation.
The mobile research units also have a support vehicle to supply all clinical trial supplies required for creating an on-site infusion clinic for patients who may otherwise cannot take part in a clinical study because of lack of access.
Earlier this month, Lilly forged a partnership with US managed care company UnitedHealth Group for undertaking a pragmatic study of bamlanivimab in high-risk, Covid-19 infected individuals.