| Autor: |
Dougan, Michael, Azizad, Masoud, Mocherla, Bharat, Gottlieb, Robert L, Chen, Peter, Hebert, Corey, Perry, Russell, Boscia, Joseph, Heller, Barry, Morris, Jason, Crystal, Chad, Igbinadolor, Awawu, Huhn, Gregory, Cardona, Jose, Shawa, Imad, Kumar, Princy, Blomkalns, Andra, Adams, Andrew C, Naarden, Jacob Van, Custer, Kenneth L |
| Předmět: |
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| Zdroj: |
Clinical Infectious Diseases; Jul2022, Vol. 75 Issue 1, pe440-e449, 10p |
| Abstrakt: |
Background Based on interim analyses and modeling data, lower doses of bamlanivimab and etesevimab together (700/1400 mg) were investigated to determine optimal dose and expand availability of treatment. Methods 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 coronavirus disease 2019 (COVID-19), and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700/1400 mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test. Results In total, 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 (Δ[95% confidence interval {CI}] = −5.0 [−8.0, −2.1], P < .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 (Δ[95% CI] = −0.99 [−1.33, −.66], P < .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. Conclusions These data support the use of bamlanivimab and etesevimab (700/1400 mg) for ambulatory patients at high risk for severe COVID-19. Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants will require continued monitoring to determine the applicability of this treatment. Clinical Trials Registration NCT04427501. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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