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