Treatments offering early intervention against COVID-19 will play a crucial role in the months before vaccines are widely available, say the partners.
“Our proactive, risk-based enrollment tied to coordinated testing and treatment will speed up the process and improve health equity,” a spokesperson for UnitedHealth told us.
The study, UNITED (NCT04639479), brings together symptom tracking, in-home testing and in-home infusions to detect, intercept and treat COVID-19 early.
Bamlanivimab recently received 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 COVID-19 and/or hospitalization.
The trial will evaluate the efficacy and safety of the neutralizing antibody versus a propensity-matched control in individuals that meet the EUA criteria. The idea is to identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations, said the companies.
The study will draw upon both UnitedHealth Group's health benefits and services businesses to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.
Delivering bamlanivimab to patients through home infusions allows them to stay quarantined and at home, minimizing the potential spread of COVID-19, said the partners.
"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 Daniel Skovronsky, Lilly's CSO and president of Lilly Research Laboratories.
Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available, commented Ken Ehlert, CSO, UnitedHealth Group and CEO of OptumLabs, the scientific research arm of 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,” he added.
Study design
UNITED (NCT04639479) is an open-label, pragmatic study designed to assess the efficacy and safety of bamlanivimab versus a propensity matched cohort for the treatment of symptomatic COVID-19 in the outpatient setting.
To be eligible, patients must meet the criteria in the Emergency Use Authorization for bamlanivimab.
Trial participants will track for symptom development and upon reporting symptoms be tested for COVID-19. If positive, they will receive a one-time at-home infusion of 700 mg bamlanivimab.
The primary objective is to determine the incidence of COVID-related hospitalization at day 28 among bamlanivimab-treated participants relative to external, propensity-matched controls.
Additional endpoints include the incidence of COVID-related mortality at day 28, as well as safety. The study will enroll up to 500,000 people, with at least 5,000 expected to receive bamlanivimab therapy.
Development of the monoclonal antibody
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It 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 (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.
US government buys more doses
Meanwhile, the US government has purchased 650,000 additional doses of the neutralizing antibody, paying just over US$812m for those volumes.
Lilly said the doses will be delivered through January 31, 2021, with at least 350,000 of the additional doses delivered in December 2020.
This purchase brings the total doses of bamlanivimab purchased by the US government to 950,000.
As previously announced by the US authorities, Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product's administration.
Doses of bamlanivimab are being manufactured at numerous sites throughout the world and the supply is expected to "increase substantially" in 2021, said Lilly.
Clinical trials
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628).
A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing, testing bamlanivimab alone and in combination with a second antibody. Data from the monotherapy arms of BLAZE-1 were published in the New England Journal of Medicine.
A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing.
In addition, bamlanivimab is being tested in the US National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.