Eli Lilly, UnitedHealth Group Launch Study of COVID-19 Antibody
The study of Eli Lilly & Company’s COVID-19 antibody, LY-CoV555, will identify and treat nearly 500,000 high-risk individuals infected with the virus under real-world conditions.
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By - Eli Lilly and Company and UnitedHealth Group recently announced a partnership to conduct a pragmatic study of the COVID-19 antibody LY-CoV555 in high-risk individuals infected with the virus.
The study will identify and treat nearly 500,000 high-risk individuals with LY-CoV555 under real-world conditions with the intent to reduce the severity of illness and hospitalizations.
The companies stated that the study will leverage UnitedHealth Group’s health benefits business and its Optum health services to detect symptomatic patients infected with COVID-19 and track their symptoms, provide in-home COVID-19 testing, and in-home infusion services.
“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,” Daniel Skovronsky, MD, PhD, Eli Lilly & Company’s chief scientific officer and president of Lilly Research Laboratories, said in the announcement.
“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,” Skovronsky continued.
In mid-November, FDA issued an emergency use authorization for LY-CoV555 for use in mild-to-moderate COVID-19 in adults and pediatric patients.
The emergency use authorization allows healthcare providers to administer a single-dose of LY-CoV555 in infected patients 12 years of age or older as long as they weigh at least 88 pounds. The authorization also states that the treatment be administered to patients who are at risk for severe COVID-19 or hospitalization. This includes patients 65 years of age or older with underlying medical conditions.
But the FDA did not authorize the antibody treatment for use in hospitalized patients or patients who require oxygen therapy due to the virus.
The authorization was based on available evidence from the Phase 2 BLAZE-1 trial, which found that patients treated with LY-CoV555 showed reduced viral load and rates of symptoms and hospitalization. Specifically, LY-CoV555 reduced coronavirus-related hospitalizations or emergency room visits in patients within 28 days after treatment compared to a placebo group.
Under Eli Lilly & Company and UnitedHealth Group’s study, delivering LY-CoV555 to infected patients through home infusions will allow them to stay quarantined at home and reduce the spread of COVID-19.
Additionally, UnitedHealthcare Medicare Advantage members who meet FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, which is a virtual community and technology platform for citizen scientists, UnitedHealth Group stated.
All volunteers will be asked to download Optum’s symptom-checking ProtectWell application and complete a daily questionnaire. Patients who experience symptoms of the coronavirus will take an at-home COVID-19 test.
Individuals who are positive for COVID-19 will receive outreach from a pharmacy nurse to schedule a home infusion treatment of LY-CoV555.
“Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available,” said Ken Ehlert, chief scientific officer at UnitedHealth Group.
“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,” added Ehlert, who is also the chief executive officer of OptumLabs.
Eli Lilly & Company’s COVID-19 antibody has shown promise in clinical trials since the start of the pandemic.
In mid-November, HHS announced that it will allocate initial doses of LY-CoV555. The agreement will also allow the federal government to obtain nearly 650,000 additional doses if needed through June of next year for up to $812.5 million.
