Lars Jørgen Østergaard

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

Standard

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. / ACTIV-3/TICO LY-CoV555 Study Group.

In: The New England Journal of Medicine, Vol. 384, No. 10, 03.2021, p. 905-914.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

Harvard

ACTIV-3/TICO LY-CoV555 Study Group 2021, 'A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19', The New England Journal of Medicine, vol. 384, no. 10, pp. 905-914. https://doi.org/10.1056/NEJMoa2033130

APA

ACTIV-3/TICO LY-CoV555 Study Group (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

CBE

ACTIV-3/TICO LY-CoV555 Study Group. 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

ACTIV-3/TICO LY-CoV555 Study Group. "A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19". The New England Journal of Medicine. 2021, 384(10). 905-914. https://doi.org/10.1056/NEJMoa2033130

Vancouver

ACTIV-3/TICO LY-CoV555 Study Group. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. The New England Journal of Medicine. 2021 Mar;384(10):905-914. https://doi.org/10.1056/NEJMoa2033130

Author

ACTIV-3/TICO LY-CoV555 Study Group. / 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{f31200af4c9e429098244f4f1fc165d1,
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}",
note = "Copyright {\textcopyright} 2020 Massachusetts Medical Society.",
year = "2021",
month = mar,
doi = "10.1056/NEJMoa2033130",
language = "English",
volume = "384",
pages = "905--914",
journal = "The New England Journal of Medicine",
issn = "0028-4793",
publisher = "MASSACHUSETTS MEDICAL SOC",
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

N1 - Copyright © 2020 Massachusetts Medical Society.

PY - 2021/3

Y1 - 2021/3

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 - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 10

ER -