, том 384 , издание 10 , страницы 905-914

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

Тип публикации: Journal Article

Дата публикации: 2020-12-22

Massachusetts Medical Society

New England Journal of Medicine

SCImago Q1

Tоп 10% SCImago

WOS Q1

БС1

SJR: 18.397

CiteScore: 74.8

Impact factor: 84.5

ISSN: 00284793, 15334406

DOI: 10.1056/NEJMoa2033130

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PubMed ID: 33356051

General Medicine

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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 -

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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}

}

Издатель

Massachusetts Medical Society

Журнал

New England Journal of Medicine

SCImago Q1

Tоп 10% SCImago

WOS Q1

БС1

SJR

18.397

CiteScore

74.8

Impact factor

84.5

ISSN

00284793

15334406

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