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

Introduction 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 The EUA of BAM + ETE was revoked (December 14, 2023) due to the high...

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Bibliographic Details
Published in:Infectious diseases and therapy 2024-10, Vol.13 (10), p.2123-2134
Main Authors: Patel, Dipak R., Macpherson, Lisa, Bohm, Martin, Upadhyaya, Himanshu, Deveau, Carmen, Nirula, Ajay, Klekotka, Paul, Williams, Mark, Hufford, Matthew M.
Format: Article
Language:English
Subjects:
Bamlanivimab
BLAZE-1
Clinical trial
COVID-19
Drug dosages
Etesevimab
Health aspects
Infectious Diseases
Internal Medicine
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Monoclonal antibodies
Original Research
Pharmaceutical industry
Risk factors
Safety
Severe acute respiratory syndrome coronavirus 2
Treatment
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Summary:Introduction 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 The EUA of BAM + ETE was revoked (December 14, 2023) due to the high prevalence of BAM + ETE-resistant variants of SARS-CoV-2.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. Methods 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. Results 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  
ISSN:2193-8229
2193-6382
DOI:10.1007/s40121-024-01031-z