On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Eli Lilly for bamlanivimab (LY-CoV555), an investigational monoclonal antibody therapy, for the treatment of mild to moderate COVID-19 in adult and pediatric patients 12 years or older weighing at least 40 kg and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Monoclonal antibodies could potentially be associated with worsening outcomes when used in hospitalized patients with severe COVID-19, therefore bamlanivimab is not authorized for use in patients that have already been hospitalized or require oxygen therapy due to COVID-19. Bamlanivimab must be administered as a single dose intravenously by trained healthcare providers. [1-2]
Prior to the FDA issuance of EUA, Eli Lilly company has conducted a randomized, double-blind, placebo-controlled, phase II study, BLAZE-1, to evaluate the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of outpatient COVID-19. Included patients were not hospitalized, had symptoms of mild or moderate COVID-19, and confirmed positive for SARS-CoV-2 within 3 days. Patients were to be given bamlanivimab 700 mg, 2,800 mg, 7,000 mg, or placebo. The primary outcome of this study is the change from baseline to day 11 in the SARS-CoV-2 viral load. The data from this interim analysis has been published with promising results [Table 1]. A phase III study, BLAZE-2, is also ongoing with the hope of using bamlanivimab as prevention of COVID-19 in long-term care facilities. [3-4]
A phase III randomized, double-blind, placebo-controlled trial (BLAZE-2) is currently being conducted with 2,400 enrolled participants. This study is looking to evaluate whether bamlanivimab can prevent SARS-CoV-2 infection and COVID-19 in residents and staff in skilled nursing or assisted living facilities. Inclusion criteria includes resident or staff in skilled nursing or assisted living facilities with at least one confirmed case of direct SARS-CoV-2 detection ≤7 days and men or non-pregnant women. Exclusion criteria include a history of confirmed COVID-19 and previously treated with monoclonal antibodies or received an investigational vaccine. Participants are randomized to receive either bamlanivimab IV or placebo. The primary outcome is the percentage of participants with SARS-CoV-2 infection. The primary outcome is estimated to complete by March 8, 2021, with the overall study estimated to be completed by June 29, 2021.