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Home   COVID-19 treatment studies for Bamlanivimab/etesevimab  COVID-19 treatment studies for Bamlaniv../e..  C19 studies: Bamlaniv../e..  Bamlaniv../e..   Select treatmentSelect treatmentTreatmentsTreatments
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All Studies   Meta Analysis   Recent: 
0 0.5 1 1.5 2+ Hospitalization or ER visit 84% Improvement Relative Risk c19early.com/l Lilly et al. NCT04427501 Bamlaniv../e.. RCT EARLY Favors bamlanivimab/e.. Favors control
Lilly, 268 patient bamlanivimab/etesevimab early treatment RCT: 84% lower hospitalization [p=0.05] https://c19p.org/lilly
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SARS-CoV-2 neutralizing antibody program update
Lilly, Press Release (Preprint), NCT04427501 (history)
7 Oct 2020    Source   PDF   Share   Tweet
Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization.
Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p<0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.
The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p=0.049). This was also similar to observations for LY-CoV555 monotherapy.
Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered).
NCT04427501 (history)
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan].
risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.049, treatment 112, control 156.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lilly et al., 7 Oct 2020, Randomized Controlled Trial, USA, preprint, 1 author, trial NCT04427501 (history).
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