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A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

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  • Jens D Lundgren
  • Birgit Grund
  • Christina E Barkauskas
  • Thomas L Holland
  • Robert L Gottlieb
  • Uriel Sandkovsky
  • Samuel M Brown
  • Kirk U Knowlton
  • Wesley H Self
  • D Clark Files
  • Mamta K Jain
  • Thomas Benfield
  • Michael E Bowdish
  • Bradley G Leshnower
  • Jason V Baker
  • Jens-Ulrik Jensen
  • Edward M Gardner
  • Adit A Ginde
  • Estelle S Harris
  • Isik S Johansen
  • Norman Markowitz
  • Michael A Matthay
  • Lars Østergaard
  • Christina C Chang
  • Victoria J Davey
  • Anna Goodman
  • Elizabeth S Higgs
  • Daniel D Murray
  • Thomas A Murray
  • Roger Paredes
  • Mahesh K B Parmar
  • Andrew N Phillips
  • Cavan Reilly
  • Shweta Sharma
  • Robin L Dewar
  • Marc Teitelbaum
  • Deborah Wentworth
  • Huyen Cao
  • Paul Klekotka
  • Abdel G Babiker
  • Annetine C Gelijns
  • Virginia L Kan
  • Mark N Polizzotto
  • B Taylor Thompson
  • H Clifford Lane
  • James D Neaton
  • ACTIV-3/TICO LY-CoV555 Study Group
  • Tomas Østergaard Jensen (Member of study group)
  • Birgitte Lindegaard Madsen (Member of study group)
  • Marie Helleberg (Member of study group)
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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.).

Original languageEnglish
Article number2033130
JournalThe New England journal of medicine
Volume384
Issue number10
Pages (from-to)905-914
Number of pages10
ISSN0028-4793
DOIs
Publication statusPublished - 11 Mar 2021

Bibliographical note

Publisher Copyright:
Copyright © 2020 Massachusetts Medical Society.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

ID: 61633106