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bamlanivimab/etesevimab (n=112) vs. placebo (n=156)
randomized controlled trial
bamlanivimab 2800 mg and etesevimab 2800 mg
placebo
5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab
COVID 19 outpatients
double-blind
Phase 2. Exploratory trial, originally designed as a safety and biomarker study.
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
bamlanivimab/etesevimab (n=518) vs. placebo (n=517)
randomized controlled trial
bamlanivimab 2,800 mg plus etesevimab 2,800 mg
single intravenous (IV) infusion within 3 days of having a positive result on a SARS-CoV-2 virologic test
placebo
COVID 19 outpatients
Participants were excluded if they had a saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/min, or heart rate ≥125 bpm
double-blind
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
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