UnitedHealth Group is partnering with Eli Lilly to test the efficacy of its COVID-19 monoclonal antibody treatment, bamlanivimab, for patients at high risk of adverse outcomes.
Bamlanivimab has not been approved by the Food and Drug Administration for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19, the companies said.
However, bamlanivimab has received Emergency Use Authorization from the FDA to treat mild and moderate COVID-19 symptoms for patients at high risk of progressing to more severe illness and/or hospitalization.
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The study will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in individuals who meet the EUA criteria. Under the study design, UnitedHealthcare Medicare Advantage members who meet the FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, a UnitedHealth Group virtual community and technology platform for citizen scientists.
The trial will draw upon both UnitedHealth Group's UnitedHealthcare health benefits business, as well as its Optum health services business, to detect and treat high-risk symptomatic patients who test positive for COVID-19. Care includes daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.
Those who volunteer will be directed to download Optum's symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test that they will self-administer and return. Those who are COVID-19-positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab.
The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy. This is part of a collaborative partnership between OptumLabs, the scientific research arm of UnitedHealth Group, and Lilly.
WHY THIS MATTERS
Treatments offering early intervention against COVID-19 will play a crucial role in the weeks and months before vaccines are widely available. The proactive, risk-based enrollment in the trial is tied to coordinated testing and treatment, and will speed up the process and improve health equity, according to the companies.
The study will identify and treat a large, diverse population of high-risk individuals with a goal of reducing the severity of illness and hospitalizations.
Bamlanivimab is not authorized for use in patients who are: hospitalized with COVID-19; require oxygen therapy due to COVID-19; or who require an increase in baseline oxygen flow rate due to underlying non-COVID-19 related comorbidity.
Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high-flow oxygen or mechanical ventilation with COVID-19. There is limited clinical data available for bamlanivimab. There is a potential for serious hypersensitivity reaction, including anaphylaxis, or infusion-related reactions.
Bamlanivimab is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. It emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.
Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19. A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
ON THE RECORD
"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," said Dr. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories. "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."
"Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available," said Ken Ehlert, chief scientific officer of UnitedHealth Group and chief executive officer of OptumLabs. "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."
THE LARGER TREND: THE STATE OF VACCINES
Moderna and Pfizer are both ready to go with their COVID-19 vaccines by mid-December, according to Operation Warp Speed. Both drug companies have filed for emergency use authorization with the Food and Drug Administration. The FDA has scheduled meetings of its vaccine advisory committee to review the Pfizer vaccine on Thursday, December 10, and the Moderna vaccine on Thursday, December 17.
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