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A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

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Harvard

Lundgren, JD, Grund, B, Barkauskas, CE, Holland, TL, Gottlieb, RL, Sandkovsky, U, Brown, SM, Knowlton, KU, Self, WH, Files, DC, Jain, MK, Benfield, T, Bowdish, ME, Leshnower, BG, Baker, JV, Jensen, J-U, Gardner, EM, Ginde, AA, Harris, ES, Johansen, IS, Markowitz, N, Matthay, MA, Østergaard, L, Chang, CC, Davey, VJ, Goodman, A, Higgs, ES, Murray, DD, Murray, TA, Paredes, R, Parmar, MKB, Phillips, AN, Reilly, C, Sharma, S, Dewar, RL, Teitelbaum, M, Wentworth, D, Cao, H, Klekotka, P, Babiker, AG, Gelijns, AC, Kan, VL, Polizzotto, MN, Thompson, BT, Lane, HC, Neaton, JD, ACTIV-3/TICO LY-CoV555 Study Group, Østergaard Jensen, T, Lindegaard Madsen, B & Helleberg, M 2021, 'A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19', The New England journal of medicine, vol. 384, no. 10, 2033130, pp. 905-914. https://doi.org/10.1056/NEJMoa2033130

APA

Lundgren, J. D., Grund, B., Barkauskas, C. E., Holland, T. L., Gottlieb, R. L., Sandkovsky, U., Brown, S. M., Knowlton, K. U., Self, W. H., Files, D. C., Jain, M. K., Benfield, T., Bowdish, M. E., Leshnower, B. G., Baker, J. V., Jensen, J-U., Gardner, E. M., Ginde, A. A., Harris, E. S., ... Helleberg, M. (2021). A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. The New England journal of medicine, 384(10), 905-914. [2033130]. https://doi.org/10.1056/NEJMoa2033130

CBE

Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen J-U, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Østergaard L, Chang CC, Davey VJ, Goodman A, Higgs ES, Murray DD, Murray TA, Paredes R, Parmar MKB, Phillips AN, Reilly C, Sharma S, Dewar RL, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD, ACTIV-3/TICO LY-CoV555 Study Group, Østergaard Jensen T, Lindegaard Madsen B, Helleberg M. 2021. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. The New England journal of medicine. 384(10):905-914. https://doi.org/10.1056/NEJMoa2033130

MLA

Vancouver

Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U et al. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. The New England journal of medicine. 2021 Mar 11;384(10):905-914. 2033130. https://doi.org/10.1056/NEJMoa2033130

Author

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 ; ACTIV-3/TICO LY-CoV555 Study Group ; Østergaard Jensen, Tomas ; Lindegaard Madsen, Birgitte ; Helleberg, Marie . / A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. In: The New England journal of medicine. 2021 ; Vol. 384, No. 10. pp. 905-914.

Bibtex

@article{6d980d3c59344734966ec462d2597ed3,
title = "A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19",
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.).",
author = "Lundgren, {Jens D} and Birgit Grund and Barkauskas, {Christina E} and Holland, {Thomas L} and Gottlieb, {Robert L} and Uriel Sandkovsky and Brown, {Samuel M} and Knowlton, {Kirk U} and Self, {Wesley H} and Files, {D Clark} and Jain, {Mamta K} and Thomas Benfield and Bowdish, {Michael E} and Leshnower, {Bradley G} and Baker, {Jason V} and Jens-Ulrik Jensen and Gardner, {Edward M} and Ginde, {Adit A} and Harris, {Estelle S} and Johansen, {Isik S} and Norman Markowitz and Matthay, {Michael A} and Lars {\O}stergaard and Chang, {Christina C} and Davey, {Victoria J} and Anna Goodman and Higgs, {Elizabeth S} and Murray, {Daniel D} and Murray, {Thomas A} and Roger Paredes and Parmar, {Mahesh K B} and Phillips, {Andrew N} and Cavan Reilly and Shweta Sharma and Dewar, {Robin L} and Marc Teitelbaum and Deborah Wentworth and Huyen Cao and Paul Klekotka and Babiker, {Abdel G} and Gelijns, {Annetine C} and Kan, {Virginia L} and Polizzotto, {Mark N} and Thompson, {B Taylor} and Lane, {H Clifford} and Neaton, {James D} and {ACTIV-3/TICO LY-CoV555 Study Group} and {{\O}stergaard Jensen}, Tomas and {Lindegaard Madsen}, Birgitte and Marie Helleberg",
note = "Publisher Copyright: Copyright {\textcopyright} 2020 Massachusetts Medical Society. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = mar,
day = "11",
doi = "10.1056/NEJMoa2033130",
language = "English",
volume = "384",
pages = "905--914",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "10",

}

RIS

TY - JOUR

T1 - A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

AU - Lundgren, Jens D

AU - Grund, Birgit

AU - Barkauskas, Christina E

AU - Holland, Thomas L

AU - Gottlieb, Robert L

AU - Sandkovsky, Uriel

AU - Brown, Samuel M

AU - Knowlton, Kirk U

AU - Self, Wesley H

AU - Files, D Clark

AU - Jain, Mamta K

AU - Benfield, Thomas

AU - Bowdish, Michael E

AU - Leshnower, Bradley G

AU - Baker, Jason V

AU - Jensen, Jens-Ulrik

AU - Gardner, Edward M

AU - Ginde, Adit A

AU - Harris, Estelle S

AU - Johansen, Isik S

AU - Markowitz, Norman

AU - Matthay, Michael A

AU - Østergaard, Lars

AU - Chang, Christina C

AU - Davey, Victoria J

AU - Goodman, Anna

AU - Higgs, Elizabeth S

AU - Murray, Daniel D

AU - Murray, Thomas A

AU - Paredes, Roger

AU - Parmar, Mahesh K B

AU - Phillips, Andrew N

AU - Reilly, Cavan

AU - Sharma, Shweta

AU - Dewar, Robin L

AU - Teitelbaum, Marc

AU - Wentworth, Deborah

AU - Cao, Huyen

AU - Klekotka, Paul

AU - Babiker, Abdel G

AU - Gelijns, Annetine C

AU - Kan, Virginia L

AU - Polizzotto, Mark N

AU - Thompson, B Taylor

AU - Lane, H Clifford

AU - Neaton, James D

AU - ACTIV-3/TICO LY-CoV555 Study Group

A2 - Østergaard Jensen, Tomas

A2 - Lindegaard Madsen, Birgitte

A2 - Helleberg, Marie

N1 - Publisher Copyright: Copyright © 2020 Massachusetts Medical Society. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/3/11

Y1 - 2021/3/11

N2 - 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.).

AB - 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.).

UR - http://www.scopus.com/inward/record.url?scp=85099949020&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2033130

DO - 10.1056/NEJMoa2033130

M3 - Journal article

C2 - 33356051

VL - 384

SP - 905

EP - 914

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 10

M1 - 2033130

ER -

ID: 61633106