JAMA - Journal of the American Medical Association, volume 325, issue 7, pages 632
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19
Robert L. Gottlieb
1
,
Ajay Nirula
2
,
Peter Chen
3
,
Joseph Boscia
4
,
Barry Heller
5
,
Jason Morris
6
,
Gregory Huhn
7
,
Jose Cardona
8
,
Bharat Mocherla
9
,
V. Stosor
10
,
Imad Shawa
11
,
Princy Kumar
12
,
Andrew P. Adams
2
,
Jacob Van Naarden
2
,
Kenneth L. Custer
2
,
Michael Durante
2
,
Gerard Oakley
2
,
Andrew E. Schade
2
,
Timothy R. Holzer
2
,
P. Ebert
2
,
Richard Higgs
2
,
Nicole Kallewaard
2
,
Janelle Sabo
2
,
Dipak R Patel
2
,
Paul Klekotka
2
,
Lei Shen
2
,
Daniel M. Skovronsky
2
2
Eli Lilly and Company, Indianapolis, Indiana
|
3
Department of Medicine, Women’s Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California
|
4
Vitalink Research, Union, South Carolina
|
5
Long Beach Clinical Trials, Long Beach, California
|
6
Imperial Health, Lake Charles, Louisiana
|
7
Cook County Health, Chicago, Illinois
|
8
Indago Research, Hialeah, Florida
|
9
Las Vegas Medical Research Center, Las Vegas, Nevada
|
11
Franciscan Health, Greenwood, Indiana
|
Publication type: Journal Article
Publication date: 2021-02-16
Quartile SCImago
Q1
Quartile WOS
Q1
Impact factor: 120.7
ISSN: 00029955, 00987484, 15383598
PubMed ID:
33475701
General Medicine
Abstract
Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19.To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19.The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020.Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156).The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29).Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment.Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point.ClinicalTrials.gov Identifier: NCT04427501.
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- We do not take into account publications without a DOI.
- Statistics recalculated only for publications connected to researchers, organizations and labs registered on the platform.
- Statistics recalculated weekly.
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Gottlieb R. L. et al. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 // JAMA - Journal of the American Medical Association. 2021. Vol. 325. No. 7. p. 632.
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Gottlieb R. L., Nirula A., Chen P., Boscia J., Heller B., Morris J., Huhn G., Cardona J., Mocherla B., Stosor V., Shawa I., Kumar P., Adams A. P., Van Naarden J., Custer K. L., Durante M., Oakley G., Schade A. E., Holzer T. R., Ebert P., Higgs R., Kallewaard N., Sabo J., Patel D. R., Klekotka P., Shen L., Skovronsky D. M. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 // JAMA - Journal of the American Medical Association. 2021. Vol. 325. No. 7. p. 632.
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TY - JOUR
DO - 10.1001/jama.2021.0202
UR - https://doi.org/10.1001/jama.2021.0202
TI - Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19
T2 - JAMA - Journal of the American Medical Association
AU - Gottlieb, Robert L.
AU - Nirula, Ajay
AU - Chen, Peter
AU - Boscia, Joseph
AU - Heller, Barry
AU - Morris, Jason
AU - Huhn, Gregory
AU - Cardona, Jose
AU - Mocherla, Bharat
AU - Stosor, V.
AU - Shawa, Imad
AU - Kumar, Princy
AU - Adams, Andrew P.
AU - Van Naarden, Jacob
AU - Custer, Kenneth L.
AU - Durante, Michael
AU - Oakley, Gerard
AU - Schade, Andrew E.
AU - Holzer, Timothy R.
AU - Ebert, P.
AU - Higgs, Richard
AU - Kallewaard, Nicole
AU - Sabo, Janelle
AU - Patel, Dipak R
AU - Klekotka, Paul
AU - Shen, Lei
AU - Skovronsky, Daniel M.
PY - 2021
DA - 2021/02/16 00:00:00
PB - American Medical Association (AMA)
SP - 632
IS - 7
VL - 325
PMID - 33475701
SN - 0002-9955
SN - 0098-7484
SN - 1538-3598
ER -
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@article{2021_Gottlieb,
author = {Robert L. Gottlieb and Ajay Nirula and Peter Chen and Joseph Boscia and Barry Heller and Jason Morris and Gregory Huhn and Jose Cardona and Bharat Mocherla and V. Stosor and Imad Shawa and Princy Kumar and Andrew P. Adams and Jacob Van Naarden and Kenneth L. Custer and Michael Durante and Gerard Oakley and Andrew E. Schade and Timothy R. Holzer and P. Ebert and Richard Higgs and Nicole Kallewaard and Janelle Sabo and Dipak R Patel and Paul Klekotka and Lei Shen and Daniel M. Skovronsky},
title = {Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19},
journal = {JAMA - Journal of the American Medical Association},
year = {2021},
volume = {325},
publisher = {American Medical Association (AMA)},
month = {feb},
url = {https://doi.org/10.1001/jama.2021.0202},
number = {7},
pages = {632},
doi = {10.1001/jama.2021.0202}
}
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Gottlieb, Robert L., et al. “Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19.” JAMA - Journal of the American Medical Association, vol. 325, no. 7, Feb. 2021, p. 632. https://doi.org/10.1001/jama.2021.0202.
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