COVID-19: bamlanivimab plus etesevimab cuts viral load in mild-moderate disease

  • Gottlieb RL & al.
  • JAMA
  • 16 Feb 2021

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • A cocktail of 2 experimental antispike monoclonal antibodies, bamlanivimab+etesevimab, significantly reduces SARS-CoV-2 viral load in outpatients with mild to moderate COVID-19.
  • Bamlanivimab monotherapy does not cut viral load at any of 3 dose levels, according to the final results of the phase 2/3 BLAZE-1 trial.

Why this matters

  • Therapies are needed for mild to moderate COVID-19.
  • A previous report of the interim results of the trial found that only 1 of the bamlanivimab doses was effective, but the interim report did not provide any results about the combination therapy.

Study design

  • Multicenter, randomized, placebo-controlled trial (N=577) of 3 doses of bamlanivimab monotherapy (single infusion of 700, 2800, or 7000 mg), the combination of bamlanivimab (2800 mg) plus etesevimab (2800 mg), or placebo.
  • Primary outcome: change in SARS-CoV-2 viral load at day 11.
  • Funding: Eli Lilly and Company.

Key findings

  • Only the combination therapy vs placebo was effective in reducing viral load (change from baseline to day 11, mean):
    • Bamlanivimab 700 mg: 0.09 (P=.69).
    • Bamlanivimab 2800 mg: −0.27 (P=.21).
    • Bamlanivimab 7000 mg: 0.31 (P=.16).
    • Combination of bamlanivimab+etesevimab: −0.57 (P=.01).
  • 10 of 84 secondary outcomes were significant.
  • 9 patients reported immediate hypersensitivity reactions.

Limitations

  • Trial was not originally designed as an efficacy trial but as a safety and biomarker study.