Eli Lilly and Company (Lilly) has entered into a partnership with managed care company UnitedHealth Group to carry out a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, Covid-19 infected individuals.
Recently, bamlanivimab was granted emergency use authorization (EUA) from the US Food and Drug Administration for the treatment of Covid-19 patients having mild to moderate symptoms, who are at high risk for progressing to severe infection and/or hospitalization.
The clinical trial will assess the efficacy and safety of bamlanivimab compared to a propensity-matched control in individuals that meet the criteria of the FDA emergency use authorization.
According to Lilly, the study will identify and treat a large, diverse group of high-risk individuals for Covid-19 with bamlanivimab under real-world conditions with an objective to bring down the severity of illness and hospitalizations.
The US pharma giant said that the trial will draw upon UnitedHealth Group’s UnitedHealthcare health benefits business and also its Optum health services business for detecting and treating high-risk symptomatic patients who test positive for the novel coronavirus.
Optum health services will carry out daily symptom tracking, in-home SARS-CoV-2 testing, and also in-home infusion services.
Lilly said that administering bamlanivimab to patients via home infusions enables them to stay quarantined and at home, thereby minimizing the potential spread of the novel coronavirus.
Daniel Skovronsky – Lilly chief scientific officer and president of Lilly Research Laboratories said: “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.
“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.”
The study is part of a collaborative partnership between Lilly and OptumLabs, the scientific research arm of UnitedHealth Group.
As per the study design, members of UnitedHealthcare Medicare Advantage who meet the FDA-authorized criteria for Covid-19 treatment will be invited for taking part in the study via United in Research, the company’s virtual community and technology platform for citizen scientists.
Ken Ehlert – chief scientific officer of UnitedHealth Group and CEO of OptumLabs said: “Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available.
“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.”