Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Oct 7;385(15):1382-1392.
doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19

Michael Dougan  1 , Ajay Nirula  1 , Masoud Azizad  1 , Bharat Mocherla  1 , Robert L Gottlieb  1 , Peter Chen  1 , Corey Hebert  1 , Russell Perry  1 , Joseph Boscia  1 , Barry Heller  1 , Jason Morris  1 , Chad Crystal  1 , Awawu Igbinadolor  1 , Gregory Huhn  1 , Jose Cardona  1 , Imad Shawa  1 , Princy Kumar  1 , Andrew C Adams  1 , Jacob Van Naarden  1 , Kenneth L Custer  1 , Michael Durante  1 , Gerard Oakley  1 , Andrew E Schade  1 , Timothy R Holzer  1 , Philip J Ebert  1 , Richard E Higgs  1 , Nicole L Kallewaard  1 , Janelle Sabo  1 , Dipak R Patel  1 , Matan C Dabora  1 , Paul Klekotka  1 , Lei Shen  1 , Daniel M Skovronsky  1 ; BLAZE-1 Investigators
Collaborators, Affiliations
Clinical Trial

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19

Michael Dougan et al. N Engl J Med. .

Abstract

Background: Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications.

Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19-related hospitalization or death from any cause by day 29.

Results: A total of 1035 patients underwent randomization and received an infusion of bamlanivimab-etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab-etesevimab group had a Covid-19-related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, -4.8 percentage points; 95% confidence interval [CI], -7.4 to -2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab-etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19-related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001).

Conclusions: Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19-related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

PubMed Disclaimer

Figures

Figure 1
Figure 1. Enrollment and Trial Design.
CDC denotes Centers for Disease Control and Prevention, and SARS-CoV-2 severe acute respiratory syndrome coronavirus 2.
Figure 2
Figure 2. Kaplan–Meier Estimate of the Time to Hospitalization among High-Risk Patients Who Received Bamlanivimab–Etesevimab or Placebo.
The inset shows the same data on an enlarged y axis. Tick marks indicate censored data.
Figure 3
Figure 3. Effect of Bamlanivimab–Etesevimab on Viral Load (Days 1–11).
The mean change in the viral load from baseline to day 11 after the initiation of bamlanivimab–etesevimab or placebo is shown. The viral load was calculated from the cycle-threshold value on reverse-transcriptase–polymerase-chain-reaction assay. The error bars indicate 95% confidence intervals.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. N Engl J Med 2021;384:229-237. - PMC - PubMed
    1. Cates J, Lucero-Obusan C, Dahl RM, et al. Risk for in-hospital complications associated with COVID-19 and influenza — Veterans Health Administration, United States, October 1, 2018–May 31, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1528-1534. - PMC - PubMed
    1. Ejaz H, Alsrhani A, Zafar A, et al. COVID-19 and comorbidities: deleterious impact on infected patients. J Infect Public Health 2020;13:1833-1839. - PMC - PubMed
    1. Guan W-J, Ni Z-Y, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:1708-1720. - PMC - PubMed
    1. Piroth L, Cottenet J, Mariet A-S, et al. Comparison of the characteristics, morbidity, and mortality of COVID-19 and seasonal influenza: a nationwide, population-based retrospective cohort study. Lancet Respir Med 2021;9:251-259. - PMC - PubMed

Publication types

MeSH terms

Associated data