The following is a summary of “Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19,” published in the September 2024 issue of Infectious Disease by Patel et al.

The monoclonal antibody therapies bamlanivimab (BAM) + etesevimab (ETE) was accepted as emergency use authorization (EUA) from the US Food and Drug Administration (February 9, 2021) for mild-to-moderate COVID-19 treatment.

Researchers conducted a retrospective study to assess the efficacy and safety of the 350/700 mg dosage of BAM and ETE for treating mild-to-moderate COVID-19.

They conducted a phase 3 BLAZE-1 trial (J2X-MC-PYAB) between June 17, 2020, and April 9, 2021. Patients with mild-to-moderate COVID-19, diagnosed within 3 days of SARS-CoV-2 infection, were enrolled. A total of 354 patients were randomized (2:3) to receive either a placebo (N = 141) or 350/700 mg BAM + ETE (N = 213) over approximately 8 minutes, and the proportion of patients with persistently high SARS-CoV-2 viral load (PHVL) (log viral load > 5.27) 7 days after infusion was assessed. 

The results showed patients with mean age  53 years, 49.7% female, and 82.7% White, had 10.8% (95%CI: 6.6, 15.0; P< 0.001) of BAM + ETE-treated patients after 7 days drug infusion and 34.8% (26.9, 42.6) of placebo-treated patients had PHVL, and the viral load changed from baseline (least square mean [standard error]) was − 3.50 (0.15; P< 0.001) in BAM + ETE-treated patients versus − 2.51 (0.19) in placebo-treated patients. Numerous treatment-emergent adverse events were considered mild or moderate in severity (BAM + ETE: 6.6%; placebo: 14.2%) with no deaths. 

They concluded that treatment with BAM + ETE  reduced the proportion of patients with PHVL and led to a more significant reduction in viral load than the placebo. BAM + ETE safety profile was favorable, and infusions of over 8 minutes did not increase the incidence of adverse events compared to higher doses administered over 30-60 minutes.

Source: link.springer.com/article/10.1007/s40121-024-01031-z