A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.
Adenosine Monophosphate
/ analogs & derivatives
Adult
Aged
Alanine
/ analogs & derivatives
Antibodies, Monoclonal, Humanized
/ adverse effects
Antibodies, Neutralizing
/ adverse effects
Antiviral Agents
/ adverse effects
COVID-19
/ mortality
Double-Blind Method
Drug Therapy, Combination
Female
Glucocorticoids
/ therapeutic use
Hospitalization
Humans
Intention to Treat Analysis
Male
Middle Aged
Treatment Failure
COVID-19 Drug Treatment
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
11 03 2021
11 03 2021
Historique:
pubmed:
29
12
2020
medline:
24
3
2021
entrez:
28
12
2020
Statut:
ppublish
Résumé
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. 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. 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). 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.).
Sections du résumé
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.).
Identifiants
pubmed: 33356051
doi: 10.1056/NEJMoa2033130
pmc: PMC7781100
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antibodies, Neutralizing
0
Antiviral Agents
0
Glucocorticoids
0
remdesivir
3QKI37EEHE
Adenosine Monophosphate
415SHH325A
bamlanivimab
45I6OFJ8QH
Alanine
OF5P57N2ZX
Banques de données
ClinicalTrials.gov
['NCT04501978']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
905-914Subventions
Organisme : NHLBI NIH HHS
ID : U01 HL088942
Pays : United States
Organisme : Medical Research Council
ID : MC_UU_12023/22
Pays : United Kingdom
Organisme : NHLBI NIH HHS
ID : UM1 HL117924
Pays : United States
Organisme : United States
ID : MRC_UU_12023/23
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI136780
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23 HL153584
Pays : United States
Organisme : United States
ID : grant no. 126
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL123031
Pays : United States
Organisme : Medical Research Council
ID : MC_UU_00004/04
Pays : United Kingdom
Investigateurs
H Clifford Lane
(HC)
John Tierney
(J)
Elizabeth S Higgs
(ES)
Kevin Barrett
(K)
Betsey R Herpin
(BR)
Mary C Smolskis
(MC)
Susan E Vogel
(SE)
Laura A McNay
(LA)
Kelly Cahill
(K)
Page Crew
(P)
Matthew Kirchoff
(M)
Ratna Sardana
(R)
Sharon Segal Raim
(S)
Stacey J Adam
(SJ)
Judy Currier
(J)
Sarah Read
(S)
Eric Hughes
(E)
Rachel H Harrigan
(RH)
James D Neaton
(JD)
Laura Amos
(L)
Anita Carter
(A)
Gary Collins
(G)
Bionca Davis
(B)
Eileen Denning
(E)
Alain DuChene
(A)
Nicole Engen
(N)
Greg Grandits
(G)
Birgit Grund
(B)
Merrie Harrison
(M)
Nancy Hurlbut
(N)
Joseph Koopmeiners
(J)
Gregg Larson
(G)
Sue Meger
(S)
Shweta Sharma Mistry
(SS)
Thomas Murray
(T)
Ray Nelson
(R)
Kien Quan
(K)
Siu Fun Quan
(SF)
Cavan Reilly
(C)
Greg Thompson
(G)
David Vock
(D)
Deborah Wentworth
(D)
Annetine C Gelijns
(AC)
Alan J Moskowitz
(AJ)
Emilia Bagiella
(E)
Ellen Moquete
(E)
Karen O'Sullivan
(K)
Evan Accardi
(E)
Emily Kinzel
(E)
Gabriela Bedoya
(G)
Lopa Gupta
(L)
Jessica R Overbey
(JR)
Maria L Padillia
(ML)
Milerva Santos
(M)
Marissa A Miller
(MA)
Wendy C Taddei-Peters
(WC)
Kathleen Fenton
(K)
Peter K Smith
(PK)
Christina E Barkauskas
(CE)
Andrew M Vekstein
(AM)
Emily R Ko
(ER)
Tatyana Der
(T)
John Franzone
(J)
Noel Ivey
(N)
Thomas L Holland
(TL)
Kathleen Lane
(K)
Andrew Bouffler
(A)
Lauren M McGowan
(LM)
Ben Stallings
(B)
Jennifer Stout
(J)
Whitney Franz
(W)
Beth McLendon-Arvik
(B)
Beth A Hollister
(BA)
Dana M Giangiacomo
(DM)
Uriel Sandkovsky
(U)
Robert L Gottlieb
(RL)
Michael Mack
(M)
Mezgebe Berhe
(M)
Clinton Haley
(C)
Emma Dishner
(E)
Christopher Bettacchi
(C)
Kevin Golden
(K)
Erin Duhaime
(E)
Cedric Spak
(C)
Sarah Burris
(S)
Felecia Jones
(F)
Samantha Villa
(S)
Samantha Wang
(S)
Raven Robert
(R)
Tanquinisha Coleman
(T)
Laura Clariday
(L)
Rebecca Baker
(R)
Mariana Hurutado
(M)
Nazia Iram
(N)
Michelle Fresnedo
(M)
Allyson Davis
(A)
Kiara Leonard
(K)
Noelia Ramierez
(N)
Jon Thammavong
(J)
Krizia Duque
(K)
Emma Turner
(E)
Aaron Killian
(A)
Adriana Palacious
(A)
Edilia Solis
(E)
Janet Jerrow
(J)
Matthew Watts
(M)
Heather Whitacre
(H)
Elizabeth Cothran
(E)
Michael E Bowdish
(ME)
Zea Borok
(Z)
Noah Wald-Dickler
(N)
Douglass Hutcheon
(D)
Amytis Towfighi
(A)
May Lee
(M)
Meghan R Lewis
(MR)
Brad Spellberg
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Linda Sher
(L)
Aniket Sharma
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Anna P Olds
(AP)
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(C)
Edward Lozano
(E)
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(C)
Janet Leong
(J)
Valentina Rodina
(V)
Christine Quesada
(C)
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(L)
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Kim T Baio
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Cameron Hypes
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(RD)
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Abhijit Duggal
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Siddharth Dugar
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Debasis Sahoo
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Kiran Ashok
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Alexander H King
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Omar Mehkri
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(A)
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(OF)
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(M)
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(MK)
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(P)
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(SS)
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(Y)
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(J)
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(NA)
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(SE)
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(E)
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(GJ)
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(L)
D Clark Files
(DC)
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(KW)
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(LS)
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(J)
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Ema Rastoder
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Christina Bergsøe
(C)
Nuria M S Hissabu
(NMS)
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(BC)
Lars Østergaard
(L)
Nina Breinholt Stærke
(N)
Andreas Arnholdt Pedersen
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(V)
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(N)
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(MJ)
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(JP)
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(E)
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(M)
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(G)
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(CC)
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(S)
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(V)
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(J)
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(A)
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(H)
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(HC)
Perrine Lallemand
(P)
Amanda Kubernac
(A)
Bhakti Patel
(B)
Kenneth Smith
(K)
Robert Kubernac
(R)
Norman P Gerry
(NP)
Marie L Hoover
(ML)
Craig Brown
(C)
Nadine DuChateau
(N)
Adam Flosi
(A)
Les Johnson
(L)
Amy Treagus
(A)
Christine Wenner
(C)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 Massachusetts Medical Society.
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