COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

Treatment Dougan M, Azizad M, Mocherla B, et al. 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. Clin Infect Dis. 2022 Aug 24;75(1):e440-e449. doi: 10.1093/cid/ciab912.
Abstract

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 (?[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 (?[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.

Ratings
Discipline / Specialty Area Score
Infectious Disease
Internal Medicine
Family Medicine (FM)/General Practice (GP)
General Internal Medicine-Primary Care(US)
Comments from MORE raters

Infectious Disease rater

The monoclonal antibody combination studied in this multicenter RCT is not effective against the current predominant circulating SARS-CoV-2 BA.4/5 variants (and has lost its FDA approval). As such, the article is old history and the product studied is no longer useful in clinical practice. However, the study is very relevant because it constitutes important proof of principle that monoconal antibodies given to high-risk patients with early COVID-19 are protective against progression to severe disease with hospitalization and death if they are well matched against the contemporary circulating strain(s).

Internal Medicine rater

This article shows good results for the use of bamlamivimab and elesevimab together in viral clearance and clinical outcomes in cases of COVID 19 with different age groups and different clinical conditions. BUT this study did not include patients on renal dialysis and patients with severe liver impairment.