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A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Dougan, M., Azizad, M., Mocherla, B., Gottlieb, R. L., Chen, P., Hebert, C., Perry, R., Boscia, J., Heller, B., Morris, J., Crystal, C., Igbinadolor, A., Huhn, G., Cardona, J., Shawa, I., Kumar, P., Blomkalns, A., Adams, A. C., Van Naarden, J., Custer, K. L., Knorr, J., Oakley, G., Schade, A. E., Holzer, T. R., Ebert, P. J., Higgs, R. E., Sabo, J., Patel, D. R., Dabora, M. C., Williams, M., Klekotka, P., Shen, L., Skovronsky, D. M., Nirula, A. 2021

Abstract

Based on interim analyses and modelling data, lower doses of bamlanivimab and etesevimab together (700mg/1400mg) were investigated to determine optimal dose and expand availability of treatment.This Phase 3 portion of the BLAZE-1 trial characterized the effect of bamlanivimab with etesevimab on overall patient clinical status and virologic outcomes in ambulatory patients =12 years old, with mild-to-moderate COVID-19, and =1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700mg/1400mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test.769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients =65 years of age and median duration of symptoms; 4 days). By day 29, 4/511 patients (0.8%) in the antibody treatment group had a COVID-19-related hospitalization or any-cause death, as compared with 15/258 patients (5.8%) in the placebo group (?[95% CI]=-5.0 [-8.0, -2.1], p<0.001). No deaths occurred in the bamlanivimab and etesevimab group compared with 4 deaths (all COVID-19-related) in the placebo group. Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (?[95% CI]=-0.99 [-1.33, -0.66], p<0.0001) compared with those receiving placebo. Persistently high viral load at Day 7 correlated with COVID-19-related hospitalization or any-cause death by Day 29 in all BLAZE-1 cohorts investigated.These data support the use of bamlanivimab and etesevimab (700mg/1400mg) for ambulatory patients at high risk for severe COVID-19. Evolution of SARS-CoV-2 variants will require continued monitoring to determine the applicability of this treatment.

View details for DOI 10.1093/cid/ciab912

View details for PubMedID 34718468