The Lancet Respiratory Medicine, volume 10, issue 10, pages 972-984

Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Thomas L Holland

Adit A. Ginde

Roger Paredes

Thomas A. Murray

Nicole Engen

Greg Grandits

Andrew Vekstein

Noel Ivey

Ahmad Mourad

Uriel Sandkovsky

Robert L. Gottlieb

Mezgebe Berhe

Mamta K. Jain

Rubria Marines-Price

Barbine Tchamba Agbor Agbor

Lourdes Mateu

Sergio España-Cueto

Gemma Lladós

Eleftherios Mylonakis

RALPH ROGERS

Fadi Shehadeh

Michael R. Filbin

Kathryn A. Hibbert

Kami Kim

Thanh Tran

Peter E. Morris

Evan P. Cassity

Barbara Trautner

Lavannya M. Pandit

Kirk U. Knowlton

Lindsay Leither

Michael A. Matthay

Angela J. Rogers

Wonder Drake

Beatrice Jones

Garyfallia Poulakou

Konstantinos N Syrigos

Eduardo Fernández-Cruz

Marisa Di Natale

Eyad Almasri

Leire Balerdi-Sarasola

Sanjay R Bhagani

Katherine L. Boyle

Jonathan D. Casey

Peter Chen

David J. Douin

D. Clark Files

Huldrych F. Günthard

R. Duncan Hite

Robert C. Hyzy

Akram Khan

Moses Kibirige

Robert Kidega

Ivan Kimuli

Francis Kiweewa

Jens-Ulrik Jensen

Bradley G. Leshnower

Joseph K. Lutaakome

Prasad Manian

Vidya Menon

Jose Luis Morales-Rull

D. Shane O’Mahony

J. Scott Overcash

Srikant Ramachandruni

Jay S Steingrub

Hassan S Taha

Michael Waters

Barnaby E Young

Andrew N. Phillips

Daniel D. Murray

Tomas O Jensen

Maria L. Padilla

David Sahner

Katy Shaw-Saliba

Robin L. Dewar

Marc Teitelbaum

Ven Natarajan

M Tauseef Rehman

Sarah Pett

Fleur Hudson

Giota Touloumi

Samuel M. Brown

Wesley H. Self

Christina C. Chang

Adriana Sánchez

Amy C Weintrob

Timothy Hatlen

Birgit Grund

Shweta Sharma

Cavan S. Reilly

Pedro Garbes

Mark T Esser

Alison Templeton

Abdel G. Babiker

Victoria J. Davey

Annetine C. Gelijns

Elizabeth S. Higgs

Virginia Kan

Gail Matthews

B. Taylor Thompson

James D. Neaton

H. Clifford Lane

Jens D. Lundgren

Publication type: Journal Article

Publication date: 2022-10-01

Elsevier

Journal: The Lancet Respiratory Medicine

Quartile SCImago

Quartile WOS

Impact factor: 76.2

ISSN: 22132600, 22132619

DOI: 10.1016/S2213-2600(22)00215-6

Copy DOI

Pulmonary and Respiratory Medicine

Abstract

Summary

Background

Tixagevimab–cilgavimab is a neutralising monoclonal antibody combination hypothesised to improve outcomes for patients hospitalised with COVID-19. We aimed to compare tixagevimab–cilgavimab versus placebo, in patients receiving remdesivir and other standard care.

Methods

In a randomised, double-blind, phase 3, placebo-controlled trial, adults with symptoms for up to 12 days and hospitalised for COVID-19 at 81 sites in the USA, Europe, Uganda, and Singapore were randomly assigned in a 1:1 ratio to receive intravenous tixagevimab 300 mg–cilgavimab 300 mg or placebo, in addition to remdesivir and other standard care. Patients were excluded if they had acute organ failure including receipt of invasive mechanical ventilation, extracorporeal membrane oxygenation, vasopressor therapy, mechanical circulatory support, or new renal replacement therapy. The study drug was prepared by an unmasked pharmacist; study participants, site study staff, investigators, and clinical providers were masked to study assignment. The primary outcome was time to sustained recovery up to day 90, defined as 14 consecutive days at home after hospital discharge, with co-primary analyses for the full cohort and for participants who were neutralising antibody-negative at baseline. Efficacy and safety analyses were done in the modified intention-to-treat population, defined as participants who received a complete or partial infusion of tixagevimab–cilgavimab or placebo. This study is registered with ClinicalTrials.gov, NCT04501978 and the participant follow-up is ongoing.

Findings

From Feb 10 to Sept 30, 2021, 1455 patients were randomly assigned and 1417 in the primary modified intention-to-treat population were infused with tixagevimab–cilgavimab (n=710) or placebo (n=707). The estimated cumulative incidence of sustained recovery was 89% for tixagevimab–cilgavimab and 86% for placebo group participants at day 90 in the full cohort (recovery rate ratio [RRR] 1·08 [95% CI 0·97–1·20]; p=0·21). Results were similar in the seronegative subgroup (RRR 1·14 [0·97–1·34]; p=0·13). Mortality was lower in the tixagevimab–cilgavimab group (61 [9%]) versus placebo group (86 [12%]; hazard ratio [HR] 0·70 [95% CI 0·50–0·97]; p=0·032). The composite safety outcome occurred in 178 (25%) tixagevimab–cilgavimab and 212 (30%) placebo group participants (HR 0·83 [0·68–1·01]; p=0·059). Serious adverse events occurred in 34 (5%) participants in the tixagevimab–cilgavimab group and 38 (5%) in the placebo group.

Interpretation

Among patients hospitalised with COVID-19 receiving remdesivir and other standard care, tixagevimab–cilgavimab did not improve the primary outcome of time to sustained recovery but was safe and mortality was lower.

Funding

US National Institutes of Health (NIH) and Operation Warp Speed.

By date By citations

Top-30

Citations by journals

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Annals of Internal Medicine	Annals of Internal Medicine, 3, 4.76% Annals of Internal Medicine 3 publications, 4.76%
Infectious Diseases and Therapy	Infectious Diseases and Therapy, 3, 4.76% Infectious Diseases and Therapy 3 publications, 4.76%
Clinical Infectious Diseases	Clinical Infectious Diseases, 3, 4.76% Clinical Infectious Diseases 3 publications, 4.76%
Frontiers in Immunology	Frontiers in Immunology, 2, 3.17% Frontiers in Immunology 2 publications, 3.17%
EClinicalMedicine	EClinicalMedicine, 2, 3.17% EClinicalMedicine 2 publications, 3.17%
Clinical Microbiology and Infection	Clinical Microbiology and Infection, 2, 3.17% Clinical Microbiology and Infection 2 publications, 3.17%
The Lancet Respiratory Medicine	The Lancet Respiratory Medicine, 2, 3.17% The Lancet Respiratory Medicine 2 publications, 3.17%
Clinical and Experimental Medicine	Clinical and Experimental Medicine, 2, 3.17% Clinical and Experimental Medicine 2 publications, 3.17%
Nefrologia	Nefrologia, 2, 3.17% Nefrologia 2 publications, 3.17%
The Lancet Microbe	The Lancet Microbe, 2, 3.17% The Lancet Microbe 2 publications, 3.17%
Vaccines	Vaccines, 1, 1.59% Vaccines 1 publication, 1.59%
Transplant Infectious Disease	Transplant Infectious Disease, 1, 1.59% Transplant Infectious Disease 1 publication, 1.59%
Critical Care Medicine	Critical Care Medicine, 1, 1.59% Critical Care Medicine 1 publication, 1.59%
Molecules	Molecules, 1, 1.59% Molecules 1 publication, 1.59%
Life	Life, 1, 1.59% Life 1 publication, 1.59%
Viruses	Viruses, 1, 1.59% Viruses 1 publication, 1.59%
Bone Marrow Transplantation	Bone Marrow Transplantation, 1, 1.59% Bone Marrow Transplantation 1 publication, 1.59%
Emergency Medicine Clinics of North America	Emergency Medicine Clinics of North America, 1, 1.59% Emergency Medicine Clinics of North America 1 publication, 1.59%
Analytical Chemistry	Analytical Chemistry, 1, 1.59% Analytical Chemistry 1 publication, 1.59%
Pharmaceutics	Pharmaceutics, 1, 1.59% Pharmaceutics 1 publication, 1.59%
Expert Review of Anti-Infective Therapy	Expert Review of Anti-Infective Therapy, 1, 1.59% Expert Review of Anti-Infective Therapy 1 publication, 1.59%
Biomedicines	Biomedicines, 1, 1.59% Biomedicines 1 publication, 1.59%
Scientific Reports	Scientific Reports, 1, 1.59% Scientific Reports 1 publication, 1.59%
PLOS Global Public Health	PLOS Global Public Health, 1, 1.59% PLOS Global Public Health 1 publication, 1.59%
Current Research in Translational Medicine	Current Research in Translational Medicine, 1, 1.59% Current Research in Translational Medicine 1 publication, 1.59%
Internal Medicine Journal	Internal Medicine Journal, 1, 1.59% Internal Medicine Journal 1 publication, 1.59%
Swiss Medical Weekly	Swiss Medical Weekly, 1, 1.59% Swiss Medical Weekly 1 publication, 1.59%
International Journal of Antimicrobial Agents	International Journal of Antimicrobial Agents, 1, 1.59% International Journal of Antimicrobial Agents 1 publication, 1.59%
Journal of Clinical Medicine	Journal of Clinical Medicine, 1, 1.59% Journal of Clinical Medicine 1 publication, 1.59%
	1 2 3

Citations by publishers

	2 4 6 8 10 12 14 16 18 20
Elsevier	Elsevier, 19, 30.16% Elsevier 19 publications, 30.16%
Springer Nature	Springer Nature, 10, 15.87% Springer Nature 10 publications, 15.87%
Multidisciplinary Digital Publishing Institute (MDPI)	Multidisciplinary Digital Publishing Institute (MDPI), 8, 12.7% Multidisciplinary Digital Publishing Institute (MDPI) 8 publications, 12.7%
Oxford University Press	Oxford University Press, 4, 6.35% Oxford University Press 4 publications, 6.35%
American College of Physicians	American College of Physicians, 3, 4.76% American College of Physicians 3 publications, 4.76%
Wiley	Wiley, 3, 4.76% Wiley 3 publications, 4.76%
Frontiers Media S.A.	Frontiers Media S.A., 3, 4.76% Frontiers Media S.A. 3 publications, 4.76%
Taylor & Francis	Taylor & Francis, 3, 4.76% Taylor & Francis 3 publications, 4.76%
Cold Spring Harbor Laboratory	Cold Spring Harbor Laboratory, 2, 3.17% Cold Spring Harbor Laboratory 2 publications, 3.17%
Wolters Kluwer Health	Wolters Kluwer Health, 1, 1.59% Wolters Kluwer Health 1 publication, 1.59%
American Chemical Society (ACS)	American Chemical Society (ACS), 1, 1.59% American Chemical Society (ACS) 1 publication, 1.59%
Public Library of Science (PLoS)	Public Library of Science (PLoS), 1, 1.59% Public Library of Science (PLoS) 1 publication, 1.59%
SMW Supporting Association	SMW Supporting Association, 1, 1.59% SMW Supporting Association 1 publication, 1.59%
PagePress	PagePress, 1, 1.59% PagePress 1 publication, 1.59%
American Society for Microbiology	American Society for Microbiology, 1, 1.59% American Society for Microbiology 1 publication, 1.59%
Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii	Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii, 1, 1.59% Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii 1 publication, 1.59%
	2 4 6 8 10 12 14 16 18 20

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Holland T. L. et al. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial // The Lancet Respiratory Medicine. 2022. Vol. 10. No. 10. pp. 972-984.

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TY - JOUR

DO - 10.1016/S2213-2600(22)00215-6

UR - https://doi.org/10.1016/S2213-2600(22)00215-6

TI - Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

T2 - The Lancet Respiratory Medicine

AU - Holland, Thomas L

AU - Ginde, Adit A.

AU - Paredes, Roger

AU - Murray, Thomas A.

AU - Engen, Nicole

AU - Grandits, Greg

AU - Vekstein, Andrew

AU - Ivey, Noel

AU - Mourad, Ahmad

AU - Sandkovsky, Uriel

AU - Gottlieb, Robert L.

AU - Berhe, Mezgebe

AU - Jain, Mamta K.

AU - Marines-Price, Rubria

AU - Agbor Agbor, Barbine Tchamba

AU - Mateu, Lourdes

AU - España-Cueto, Sergio

AU - Lladós, Gemma

AU - Mylonakis, Eleftherios

AU - ROGERS, RALPH

AU - Shehadeh, Fadi

AU - Filbin, Michael R.

AU - Hibbert, Kathryn A.

AU - Kim, Kami

AU - Tran, Thanh

AU - Morris, Peter E.

AU - Cassity, Evan P.

AU - Trautner, Barbara

AU - Pandit, Lavannya M.

AU - Knowlton, Kirk U.

AU - Leither, Lindsay

AU - Matthay, Michael A.

AU - Rogers, Angela J.

AU - Drake, Wonder

AU - Jones, Beatrice

AU - Poulakou, Garyfallia

AU - Syrigos, Konstantinos N

AU - Fernández-Cruz, Eduardo

AU - Di Natale, Marisa

AU - Almasri, Eyad

AU - Balerdi-Sarasola, Leire

AU - Bhagani, Sanjay R

AU - Boyle, Katherine L.

AU - Casey, Jonathan D.

AU - Chen, Peter

AU - Douin, David J.

AU - Files, D. Clark

AU - Günthard, Huldrych F.

AU - Hite, R. Duncan

AU - Hyzy, Robert C.

AU - Khan, Akram

AU - Kibirige, Moses

AU - Kidega, Robert

AU - Kimuli, Ivan

AU - Kiweewa, Francis

AU - Jensen, Jens-Ulrik

AU - Leshnower, Bradley G.

AU - Lutaakome, Joseph K.

AU - Manian, Prasad

AU - Menon, Vidya

AU - Morales-Rull, Jose Luis

AU - O’Mahony, D. Shane

AU - Overcash, J. Scott

AU - Ramachandruni, Srikant

AU - Steingrub, Jay S

AU - Taha, Hassan S

AU - Waters, Michael

AU - Young, Barnaby E

AU - Phillips, Andrew N.

AU - Murray, Daniel D.

AU - Jensen, Tomas O

AU - Padilla, Maria L.

AU - Sahner, David

AU - Shaw-Saliba, Katy

AU - Dewar, Robin L.

AU - Teitelbaum, Marc

AU - Natarajan, Ven

AU - Rehman, M Tauseef

AU - Pett, Sarah

AU - Hudson, Fleur

AU - Touloumi, Giota

AU - Brown, Samuel M.

AU - Self, Wesley H.

AU - Chang, Christina C.

AU - Sánchez, Adriana

AU - Weintrob, Amy C

AU - Hatlen, Timothy

AU - Grund, Birgit

AU - Sharma, Shweta

AU - Reilly, Cavan S.

AU - Garbes, Pedro

AU - Esser, Mark T

AU - Templeton, Alison

AU - Babiker, Abdel G.

AU - Davey, Victoria J.

AU - Gelijns, Annetine C.

AU - Higgs, Elizabeth S.

AU - Kan, Virginia

AU - Matthews, Gail

AU - Thompson, B. Taylor

AU - Neaton, James D.

AU - Lane, H. Clifford

AU - Lundgren, Jens D.

PY - 2022

DA - 2022/10/01 00:00:00

PB - Elsevier

SP - 972-984

IS - 10

VL - 10

SN - 2213-2600

SN - 2213-2619

ER -

BibTex |

Cite this

BibTex Copy

@article{2022_Holland,

author = {Thomas L Holland and Adit A. Ginde and Roger Paredes and Thomas A. Murray and Nicole Engen and Greg Grandits and Andrew Vekstein and Noel Ivey and Ahmad Mourad and Uriel Sandkovsky and Robert L. Gottlieb and Mezgebe Berhe and Mamta K. Jain and Rubria Marines-Price and Barbine Tchamba Agbor Agbor and Lourdes Mateu and Sergio España-Cueto and Gemma Lladós and Eleftherios Mylonakis and RALPH ROGERS and Fadi Shehadeh and Michael R. Filbin and Kathryn A. Hibbert and Kami Kim and Thanh Tran and Peter E. Morris and Evan P. Cassity and Barbara Trautner and Lavannya M. Pandit and Kirk U. Knowlton and Lindsay Leither and Michael A. Matthay and Angela J. Rogers and Wonder Drake and Beatrice Jones and Garyfallia Poulakou and Konstantinos N Syrigos and Eduardo Fernández-Cruz and Marisa Di Natale and Eyad Almasri and Leire Balerdi-Sarasola and Sanjay R Bhagani and Katherine L. Boyle and Jonathan D. Casey and Peter Chen and David J. Douin and D. Clark Files and Huldrych F. Günthard and R. Duncan Hite and Robert C. Hyzy and Akram Khan and Moses Kibirige and Robert Kidega and Ivan Kimuli and Francis Kiweewa and Jens-Ulrik Jensen and Bradley G. Leshnower and Joseph K. Lutaakome and Prasad Manian and Vidya Menon and Jose Luis Morales-Rull and D. Shane O’Mahony and J. Scott Overcash and Srikant Ramachandruni and Jay S Steingrub and Hassan S Taha and Michael Waters and Barnaby E Young and Andrew N. Phillips and Daniel D. Murray and Tomas O Jensen and Maria L. Padilla and David Sahner and Katy Shaw-Saliba and Robin L. Dewar and Marc Teitelbaum and Ven Natarajan and M Tauseef Rehman and Sarah Pett and Fleur Hudson and Giota Touloumi and Samuel M. Brown and Wesley H. Self and Christina C. Chang and Adriana Sánchez and Amy C Weintrob and Timothy Hatlen and Birgit Grund and Shweta Sharma and Cavan S. Reilly and Pedro Garbes and Mark T Esser and Alison Templeton and Abdel G. Babiker and Victoria J. Davey and Annetine C. Gelijns and Elizabeth S. Higgs and Virginia Kan and Gail Matthews and B. Taylor Thompson and James D. Neaton and H. Clifford Lane and Jens D. Lundgren},

title = {Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial},

journal = {The Lancet Respiratory Medicine},

year = {2022},

volume = {10},

publisher = {Elsevier},

month = {oct},

url = {https://doi.org/10.1016/S2213-2600(22)00215-6},

number = {10},

pages = {972--984},

doi = {10.1016/S2213-2600(22)00215-6}

}

MLA

Cite this

MLA Copy

Holland, Thomas L., et al. “Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial.” The Lancet Respiratory Medicine, vol. 10, no. 10, Oct. 2022, pp. 972-984. https://doi.org/10.1016/S2213-2600(22)00215-6.

Found error?

Publisher

Elsevier

Journal

The Lancet Respiratory Medicine

Quartile SCImago

Quartile WOS

Impact factor

76.2

ISSN

22132600 (Print)
22132619 (Electronic)