The Lancet Respiratory Medicine, volume 10, issue 10, pages 985-996
Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial
HUGH MONTGOMERY
,
F.D. Richard Hobbs
,
Francisco Padilla
,
Douglas Arbetter
,
Alison Templeton
,
Seth Seegobin
,
KENNETH KIM
,
Jesus Abraham Simón Campos
,
Rosalinda H. Arends
,
Bryan H Brodek
,
Dennis Brooks
,
Pedro Garbes
,
Julieta Jimenez
,
Gavin C K W Koh
,
Kelly W. Padilla
,
Katie Streicher
,
Rolando M Viani
,
Vijay Alagappan
,
Menelas N. Pangalos
,
Mark T Esser
,
Wakana Abe
,
Tania Adan De Varona
,
Daria Adiatullina
,
Daniel Aguilar Zapata
,
Kevin Ahlers
,
Carolina Aimo
,
Ayoade Akere
,
Elena Akimova
,
Jorge Alatorre Alexander
,
Logan Aldrich
,
Ismael Ali Garcia
,
Karim Ali García
,
Lee Allison
,
Rosa Alonso Zuñiga
,
Ivan Aloysius
,
Javier Altclas
,
Andres Alvarisqueta
,
Martti Antila
,
Camila Anton
,
Elisabet Árboix Alamo
,
Samir Arora
,
Ramón Alejandro Avilés Felix
,
Natalya Bakhtina
,
Varenka Barbero-Becerra
,
Armando Barragan-Reyes
,
Alejandro Barreira
,
Barrett Mitchell
,
Jiri Beran
,
Nikolett Berki
,
Viktoria Berki
,
Richard Betten
,
Claudia Binelli
,
Lenka Brunzová
,
Cecilia Bussolari
,
Karianna Byargeon
,
Justyna Bytnar
,
Carlos Camberos
,
Pedro Campos Corzo
,
Grazia Cannon
,
Valentina Canovi
,
Simone Carla da Rosa
,
Ana Caroline Moser
,
Luis Carrera Rivas
,
Marcelo Martin Casas
,
Paulo Castañeda-Méndez
,
Ana Cavalcante
,
Eugenia Cherepova
,
Alexei Chermenskii
,
Lauren Clark
,
Mauro Codeluppi
,
Flavia Coelho
,
Belinda Contreras
,
Alex Cran
,
Taylor Dao
,
Chrisette Dharma
,
Cosimo Di Castri
,
Victoria Diaz Balocchi
,
Omar Durán
,
Kara Earl
,
Adam Ellery
,
Tomoko Endo
,
Andrea Everding
,
Rainald Fischer
,
Benedito Fonseca
,
Chelsea C. Franklin
,
Susan-Beatrice Franz
,
Anna Fumagalli
,
Mauricio Galindo-Amaya
,
Mariagiulia Galli
,
Laura Gerna
,
Karolly Gil Ureña
,
Henrikki Gomes Antila
,
Laura Ines Gomes Maricato
,
Gabriela Goncalvez
,
Martin Gonzalez
,
Jesús González-Lama
,
Stephen Granier
,
Jacob Granier
,
Stephan Grunwald
,
David Guardeño-Ropero
,
Monica Guberti
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Sridhar Guduri
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Carolina Guerrero García
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Jehad Haggiagi
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Kacie Hale
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Toshimasa Hayashi
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Maiara Hermes
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Dante Hernandez Colin
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Yuji Hirai
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Masayuki Hojo
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Tetsuya Homma
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Billy Hour
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Andreas Huber
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Diego Iacovelli
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Noriomi Ishibashi
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Yutaro Iwabe
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Shinyu Izumi
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Arne Jessen
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Heiko Jessen
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Wilner Jeudy
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Marta Jiménez Marcos
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Rebecca Johnson
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Eva Juárez-Hernández
,
Kiyomi Kabasawa
,
Katarzyna Kamińska
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Megumi Kawabe
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Angela Kemp
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Oleg Khmelnitskiy
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Carina Klassen
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Olena Kobrynska
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Pavel Koleckar
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Stephanie Korn
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Marc Kornmann
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Viktor Kostenko
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Evgenii Kovalchuk
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Yana Kovalchuk
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Tim Kümmerle
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Ulrike Lachmund
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Kerstin Lammersmann
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Ivana Lattuada
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Theresa Moll
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Rebeca Mussi Brugnolli
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Akanksha Nanda
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Dörthe Neuner
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Agatha Ngwueke
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Sebastian Noe
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Martin Novacek
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Laura Nuzzolo-Shihadeh
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Emeka Obiekwe
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Isaias G. Ocampo Gaytán
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Norio Ohmagari
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Shin Ohta
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Ptuonye Onyewuchi
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Iurii Pankov
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Maurício Pedrosa
,
Yael Peré
,
Alejandro Pereyra
,
Eliana Perez
,
Eduardo Perez-Alba
,
Paloma Perpiña Lozano
,
Tanya Perrei
,
Dena Peterson
,
Ligia Pierroti
,
Felipe Pineda-Cárdenas
,
Teresa Plascencia Sanchez
,
Camila Poletti
,
Chiara Pomaranzi
,
Lisette Portes
,
Nils Postel
,
Monica Ramirez
,
Isabel Ramírez
,
Miguel Ramirez-Baena
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Mahadev Ramjee
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Giovanna Ratti
,
Jackie Reeve
,
Petr Reichert
,
Petra Reichertová
,
Edgar Alejandro Reyes Garcia
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Celso Ricardo
,
Nicomedes Rodríguez Rodríguez
,
Jaun Roldán Sánchez
,
Matilde Romero-Lopez
,
Tyrone Rosales
,
Harvey Rosales
,
Mohamed Roshan
,
Simran Roshan
,
Patrizia Rovere Querini
,
Heather Rutter
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Sadaf Sachwani
,
Hironori Sagara
,
Jun Sakai
,
Nina Samson
,
José Héctor Sánchez Mijangos
,
Liliana Sánchez
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Fernando Solorzano
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Silvia Soncini
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Veronika Špinková
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Ruth Staniford
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Vivien Steiner
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Vladimir Strelkov
,
Cintya R. Suárez Pineda
,
Hiroki Suenaga
,
Shintaro Suzaki
,
Hannah Swayze
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Yuichiro Takeshita
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Yasuo Takiguchi
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Akihiko Tanaka
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Norihito Tarumoto
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Michelle Taubert
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Elizaveta Terenya
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César Tinoco
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Tomohiro Tomiyasu
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Gladys Torres-Vidal
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Gabriela Trejo-Aguiar
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Kenji Tsushima
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Emma Tunstall
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Caterina Turrà
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Yoandy Valdes
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Nelly Valencia Castro
,
Guilherme Visconti
,
Giordano Vitali
,
Apinya Vutikullird
,
Jezdancher Watti
,
Doreen Werth
,
Cheyanne Wilson
,
Philippe Wilson
,
Amy Workman
,
Pamela Wörle
,
Christoph Wyen
,
Yoshiko Yamaguchi
,
Kei Yamamoto
Publication type: Journal Article
Publication date: 2022-10-01
Journal:
The Lancet Respiratory Medicine
Q1
Q1
SJR: 7.965
CiteScore: 87.1
Impact factor: 38.7
ISSN: 22132600, 22132619
Pulmonary and Respiratory Medicine
Abstract
Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab-cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to evaluate the safety and efficacy of tixagevimab-cilgavimab in preventing progression to severe COVID-19 or death.TACKLE is an ongoing, phase 3, randomised, double-blind, placebo-controlled study conducted at 95 sites in the USA, Latin America, Europe, and Japan. Eligible participants were non-hospitalised adults aged 18 years or older with a laboratory-confirmed SARS-CoV-2 infection (determined by RT-PCR or an antigen test) from any respiratory tract specimen collected 3 days or less before enrolment and who had not received a COVID-19 vaccination. A WHO Clinical Progression Scale score from more than 1 to less than 4 was required for inclusion and participants had to receive the study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever. Participants were randomly assigned (1:1) to receive either a single tixagevimab-cilgavimab 600 mg dose (two consecutive 3 mL intramuscular injections, one each of 300 mg tixagevimab and 300 mg cilgavimab) or placebo. Randomisation was stratified (using central blocked randomisation with randomly varying block sizes) by time from symptom onset, and high-risk versus low-risk of progression to severe COVID-19. Participants, investigators, and sponsor staff involved in the treatment or clinical evaluation and monitoring of the participants were masked to treatment-group assignments. The primary endpoints were severe COVID-19 or death from any cause through to day 29, and safety. This study is registered with ClinicalTrials.gov, NCT04723394.Between Jan 28, 2021, and July 22, 2021, 1014 participants were enrolled, of whom 910 were randomly assigned to a treatment group (456 to receive tixagevimab-cilgavimab and 454 to receive placebo). The mean age of participants was 46·1 years (SD 15·2). Severe COVID-19 or death occurred in 18 (4%) of 407 participants in the tixagevimab-cilgavimab group versus 37 (9%) of 415 participants in the placebo group (relative risk reduction 50·5% [95% CI 14·6-71·3]; p=0·0096). The absolute risk reduction was 4·5% (95% CI 1·1-8·0; p<0·0001). Adverse events occurred in 132 (29%) of 452 participants in the tixagevimab-cilgavimab group and 163 (36%) of 451 participants in the placebo group, and were mostly of mild or moderate severity. There were three COVID-19-reported deaths in the tixagevimab-cilgavimab group and six in the placebo group.A single intramuscular tixagevimab-cilgavimab dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favourable. Treating mild to moderate COVID-19 earlier in the disease course with tixagevimab-cilgavimab might lead to more favourable outcomes.AstraZeneca.
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MONTGOMERY H. et al. Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial // The Lancet Respiratory Medicine. 2022. Vol. 10. No. 10. pp. 985-996.
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MONTGOMERY H. et al. Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial // The Lancet Respiratory Medicine. 2022. Vol. 10. No. 10. pp. 985-996.
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@article{2022_MONTGOMERY,
author = {HUGH MONTGOMERY and F.D. Richard Hobbs and Francisco Padilla and Douglas Arbetter and Alison Templeton and Seth Seegobin and KENNETH KIM and Jesus Abraham Simón Campos and Rosalinda H. Arends and Bryan H Brodek and Dennis Brooks and Pedro Garbes and Julieta Jimenez and Gavin C K W Koh and Kelly W. Padilla and Katie Streicher and Rolando M Viani and Vijay Alagappan and Menelas N. Pangalos and Mark T Esser and Wakana Abe and Tania Adan De Varona and Daria Adiatullina and Daniel Aguilar Zapata and Kevin Ahlers and Carolina Aimo and Ayoade Akere and Elena Akimova and Jorge Alatorre Alexander and Logan Aldrich and Ismael Ali Garcia and Karim Ali García and Lee Allison and Rosa Alonso Zuñiga and Ivan Aloysius and Javier Altclas and Andres Alvarisqueta and Martti Antila and Camila Anton and Elisabet Árboix Alamo and Samir Arora and Ramón Alejandro Avilés Felix and Natalya Bakhtina and Varenka Barbero-Becerra and Armando Barragan-Reyes and Alejandro Barreira and Barrett Mitchell and Jiri Beran and Nikolett Berki and Viktoria Berki and others},
title = {Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial},
journal = {The Lancet Respiratory Medicine},
year = {2022},
volume = {10},
publisher = {Elsevier},
month = {oct},
url = {https://doi.org/10.1016/S2213-2600(22)00180-1},
number = {10},
pages = {985--996},
doi = {10.1016/S2213-2600(22)00180-1}
}
Cite this
MLA
Copy
MONTGOMERY, HUGH, et al. “Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial.” The Lancet Respiratory Medicine, vol. 10, no. 10, Oct. 2022, pp. 985-996. https://doi.org/10.1016/S2213-2600(22)00180-1.