Pulse Brain · Growing Health Evidence Index
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

The TACKLE trial was a phase 3, randomised, double-blind, placebo-controlled trial examining the efficacy and safety of intramuscular tixagevimab–cilgavimab, a long-acting monoclonal antibody combination, for early outpatient treatment of COVID-19. Published in The Lancet Respiratory Medicine in 2022, the trial enrolled a large, geographically diverse population across multiple countries. As suggested by the study design and journal scope, the research aimed to establish whether this combination therapy could reduce disease severity or progression in non-hospitalised patients when administered early in infection.

UK applicability

Findings would be directly relevant to United Kingdom clinical practice and NHS outpatient COVID-19 management protocols, given the multi-national design and regulatory context of The Lancet Respiratory Medicine. However, applicability may depend on UK-specific epidemiology, variant prevalence, and integration with existing treatment guidelines at the time of publication.

Key measures

As suggested by the trial design: likely disease progression, severity, hospitalisation rates, and adverse events in early outpatient COVID-19 treatment

Outcomes reported

The study measured efficacy and safety of intramuscular tixagevimab–cilgavimab administration in non-hospitalised COVID-19 patients, as suggested by the phase 3 randomised controlled design and journal scope.

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
BFmovi1x8l-u58hx4

Topic tags

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