Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19.

Publication date: Sep 04, 2024

The monoclonal antibody therapies bamlanivimab (BAM) + etesevimab (ETE) received emergency use authorization (EUA) from the US Food and Drug Administration (February 9, 2021) for treatment of mild-to-moderate COVID-19. The EUA of BAM + ETE was revoked (December 14, 2023) due to the high prevalence of BAM + ETE-resistant variants of SARS-CoV-2. Efficacy and safety of 700/1400 mg and 2800/2800 mg BAM + ETE are well established and published; however, efficacy and safety of 350/700 mg BAM + ETE have not been disclosed to date. This portion of phase 3, BLAZE-1 trial (J2X-MC-PYAB) enrolled patients (between June 17, 2020 and April 9, 2021) with mild-to-moderate COVID-19 within 3 days of laboratory diagnosis of SARS-CoV-2 infection. In total, 354 patients with at least one risk factor for severe COVID-19 were enrolled, randomized (2:3), and infused with placebo (N = 141) or 350/700 mg BAM + ETE (N = 213), over ~ 8 min. Primary endpoint was to assess proportion of patients with persistently high SARS-CoV-2 viral load (PHVL) (log viral load > 5. 27) 7 days after infusion. Patients were aged (mean) 53 years, 49. 7% female, and 82. 7% White. Seven days after drug infusion, 10. 8% (95% confidence interval: 6. 6, 15. 0; p 

Concepts Keywords
1400mg Bamlanivimab
Food BLAZE-1
June Clinical trial
Severe COVID-19
Etesevimab
Treatment

Semantics

Type Source Name
disease MESH COVID-19
disease MESH emergency
pathway REACTOME SARS-CoV-2 Infection
disease MESH viral load

Original Article

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