The UNITED study includes symptom tracking, in-home testing and in-home infusions to detect, intercept and provide early treatment for Covid-19
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
Eli Lilly and Co. (Lilly) has partnered with UnitedHealth Group to commence a pragmatic study of bamlanivimab (LY-CoV555) in high-risk individuals infected with Covid-19.
Under the partnership, the companies will conduct a clinical trial, dubbed UNITED, to evaluate the efficacy and safety of bamlanivimab compared to a propensity-matched control in individuals that meet the EUA criteria.
Bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody (mAb) that works against the spike protein of SARS-CoV-2. The drug has been developed under collaboration between Lilly and AbCellera, for the prevention and treatment of Covid-19
Recently, bamlanivimab has been granted the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) to treat high-risk Covid-19 patients or severe Covid-19 patients who may require hospitalisation.
Lilly chief scientific officer and Lilly research laboratories president Daniel Skovronsky 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.”
OptumLabs, the scientific research business of UnitedHealth Group, will enter into a collaborative partnership with Lilly to conduct the UNITED clinical study.
The UNITED trial is planned to identify and treat a large, diverse population of high-risk individuals for Covid-19 with bamlanivimab under real-world conditions. The study also includes daily symptom tracking, in-home SARS-CoV-2 testing and infusion services.
Delivering bamlanivimab to patients through home infusions would help them stay quarantined at home, and minimises the potential spread of Covid-19, said the company.
According to the study design, UnitedHealthcare Medicare Advantage members who fit the FDA-authorised criteria for treatment will be invited as volunteers for the study.
The volunteers who would receive treatment will have to download Optum’s symptom-checking ProtectWell app and complete a daily questionnaire.
Study participants experiencing Covid-19 symptoms will self-administer at-home SARS-CoV-2 test, and Covid-19 positive participants are expected to receive help from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab.
The UNITED trial is designed to enrol up to 500,000 participants, with a goal of providing bamlanivimab treatment for at least 5,000 participants.
UnitedHealth Group chief scientific officer Ken Ehlert 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.”