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Tier 2 — RCT / large cohortPeer-reviewed

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, 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 Koh, Kelly 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, Mitchell Barrett, 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

The Lancet Respiratory Medicine · 2022

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Summary

This phase 3 randomised controlled trial, published in The Lancet Respiratory Medicine in 2022, assessed the efficacy and safety profile of tixagevimab–cilgavimab, a long-acting monoclonal antibody combination administered intramuscularly for early outpatient treatment of COVID-19. As a double-blind, placebo-controlled design with international participation, the trial aimed to evaluate whether this therapeutic approach could reduce clinical progression in symptomatic patients treated outside hospital settings. The findings contribute to the evidence base for monoclonal antibody therapies in early COVID-19 management during the pandemic response period.

UK applicability

As a global phase 3 trial with likely United Kingdom participant centres (suggested by lead author affiliation patterns and international scope), the results would be directly applicable to NHS outpatient COVID-19 treatment pathways and procurement decisions for monoclonal antibody therapeutics during the 2022 pandemic period.

Key measures

Clinical efficacy endpoints (as suggested by phase 3 trial design), safety and tolerability profiles, and adverse events associated with intramuscular monoclonal antibody administration

Outcomes reported

The study evaluated efficacy and safety of intramuscular tixagevimab–cilgavimab (a long-acting monoclonal antibody combination) versus placebo for early outpatient treatment of COVID-19. Primary outcomes as suggested by the title include clinical efficacy measures and adverse event monitoring in a phase 3 randomised controlled trial.

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s2213-2600(22)00180-1
Catalogue ID
BFmou2m94m-7tepcq

Topic tags

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