A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
, Lundgren Jens D, Grund Birgit, Barkauskas Christina E, Holland Thomas L, Gottlieb Robert L, Sandkovsky Uriel, Brown Samuel M, Knowlton Kirk U, Self Wesley H, Files D Clark, Jain Mamta K, Benfield Thomas, Bowdish Michael E, Leshnower Bradley G, Baker Jason V, Jensen Jens-Ulrik, Gardner Edward M, Ginde Adit A, Harris Estelle S, Johansen Isik S, Markowitz Norman, Matthay Michael A, Østergaard Lars, Chang Christina C, Davey Victoria J, Goodman Anna, Higgs Elizabeth S, Murray Daniel D, Murray Thomas A, Paredes Roger, Parmar Mahesh K B, Phillips Andrew N, Reilly Cavan, Sharma Shweta, Dewar Robin L, Teitelbaum Marc, Wentworth Deborah, Cao Huyen, Klekotka Paul, Babiker Abdel G, Gelijns Annetine C, Kan Virginia L, Polizzotto Mark N, Thompson B Taylor, Lane H Clifford, Neaton James D
Publication type: Journal Article
Publication date: 2020-12-22
scimago Q1
wos Q1
SJR: 19.076
CiteScore: 96.4
Impact factor: 78.5
ISSN: 00284793, 15334406
PubMed ID:
33356051
General Medicine
Abstract
Abstract Background LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. Methods In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. Results On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P=0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P=0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). Conclusions Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.)
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Lundgren J., Grund B., Barkauskas C., Holland T., Gottlieb R., Sandkovsky U., Brown S., Knowlton K., Self W., Files D., Jain M., Benfield T., Bowdish M., Leshnower B., Baker J., Jensen J., Gardner E., Ginde A., Harris E., Johansen I., Markowitz N., Matthay M., Østergaard L., Chang C., Davey V., Goodman A., Higgs E., Murray D., Murray T., Paredes R., Parmar M., Phillips A., Reilly C., Sharma S., Dewar R., Teitelbaum M., Wentworth D., Cao H., Klekotka P., Babiker A., Gelijns A., Kan V., Polizzotto M., Thompson B., Lane H., Neaton J. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 // New England Journal of Medicine. 2020. Vol. 384. No. 10. pp. 905-914.
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TY - JOUR
DO - 10.1056/NEJMoa2033130
UR - https://doi.org/10.1056/NEJMoa2033130
TI - A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
T2 - New England Journal of Medicine
AU - Lundgren, Jens
AU - Grund, Birgit
AU - Barkauskas, Christina
AU - Holland, Thomas
AU - Gottlieb, Robert
AU - Sandkovsky, Uriel
AU - Brown, Samuel
AU - Knowlton, Kirk
AU - Self, Wesley
AU - Files, D
AU - Jain, Mamta
AU - Benfield, Thomas
AU - Bowdish, Michael
AU - Leshnower, Bradley
AU - Baker, Jason
AU - Jensen, Jens-Ulrik
AU - Gardner, Edward
AU - Ginde, Adit
AU - Harris, Estelle
AU - Johansen, Isik
AU - Markowitz, Norman
AU - Matthay, Michael
AU - Østergaard, Lars
AU - Chang, Christina
AU - Davey, Victoria
AU - Goodman, Anna
AU - Higgs, Elizabeth
AU - Murray, Daniel
AU - Murray, Thomas
AU - Paredes, Roger
AU - Parmar, Mahesh
AU - Phillips, Andrew
AU - Reilly, Cavan
AU - Sharma, Shweta
AU - Dewar, Robin
AU - Teitelbaum, Marc
AU - Wentworth, Deborah
AU - Cao, Huyen
AU - Klekotka, Paul
AU - Babiker, Abdel
AU - Gelijns, Annetine
AU - Kan, Virginia
AU - Polizzotto, Mark
AU - Thompson, B
AU - Lane, H
AU - Neaton, James
PY - 2020
DA - 2020/12/22
PB - Massachusetts Medical Society
SP - 905-914
IS - 10
VL - 384
PMID - 33356051
SN - 0028-4793
SN - 1533-4406
ER -
Cite this
BibTex (up to 50 authors)
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@article{2020,
author = {Jens Lundgren and Birgit Grund and Christina Barkauskas and Thomas Holland and Robert Gottlieb and Uriel Sandkovsky and Samuel Brown and Kirk Knowlton and Wesley Self and D Files and Mamta Jain and Thomas Benfield and Michael Bowdish and Bradley Leshnower and Jason Baker and Jens-Ulrik Jensen and Edward Gardner and Adit Ginde and Estelle Harris and Isik Johansen and Norman Markowitz and Michael Matthay and Lars Østergaard and Christina Chang and Victoria Davey and Anna Goodman and Elizabeth Higgs and Daniel Murray and Thomas Murray and Roger Paredes and Mahesh Parmar and Andrew Phillips and Cavan Reilly and Shweta Sharma and Robin Dewar and Marc Teitelbaum and Deborah Wentworth and Huyen Cao and Paul Klekotka and Abdel Babiker and Annetine Gelijns and Virginia Kan and Mark Polizzotto and B Thompson and H Lane and James Neaton},
title = {A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19},
journal = {New England Journal of Medicine},
year = {2020},
volume = {384},
publisher = {Massachusetts Medical Society},
month = {dec},
url = {https://doi.org/10.1056/NEJMoa2033130},
number = {10},
pages = {905--914},
doi = {10.1056/NEJMoa2033130}
}