Tixagevimab/Cilgavimab for Treatment of Hospitalised COVID-19 Patients: A Randomised, Double-Blind, Phase 3 Trial

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

doi:10.2139/ssrn.4087355

SSRN Journal

2022

DOI: 10.2139/ssrn.4087355

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Tixagevimab/Cilgavimab for Treatment of Hospitalised COVID-19 Patients: A Randomised, Double-Blind, Phase 3 Trial

Thomas L Holland

Adit A. Ginde

Roger Paredes

et al.

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Cited by 3 publications

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Tixagevimab + Cilgavimab: First Approval

Keam

2022

Drugs

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Tixagevimab 150 mg and cilgavimab 150 mg (EVUSHELD TM 150 mg + 150 mg solution for injection; tixagevimab + cilgavimab) is an intramuscular (IM) long-acting monoclonal antibody combination developed by AstraZeneca for the prevention and treatment of COVID-19. In March 2022, tixagevimab + cilgavimab was approved in the UK for pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who are unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended, and in the EU for the prevention of COVID-19 in adults and adolescents aged ≥ 12 years and weighing ≥40 kg. In December 2021, tixagevimab + cilgavimab was granted Emergency Use Authorization by the US FDA for the pre-exposure prophylaxis of COVID-19 in adults and paediatric individuals (≥ 12 years of age and weighing ≥ 40 kg). This article summarizes the milestones in the development of tixagevimab + cilgavimab leading to this first approval for pre-exposure prophylaxis of COVID-19 in individuals who are not currently infected with SARS-CoV-2. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-022-01731-1.

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Tixagevimab + Cilgavimab: First Approval

Keam

2022

Drugs

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The effect of tixagevimab-cilgavimab on clinical outcomes in patients with COVID-19: A systematic review with meta-analysis

Wang

Zheng²,

Zhu³

et al. 2023

Journal of Infection

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Puesta en marcha de una unidad COVID de alto riesgo. La experiencia de un hospital general

Boixeda

Palau²,

Garcia³

et al. 2023

Medicina Clínica

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Tixagevimab/Cilgavimab for Treatment of Hospitalised COVID-19 Patients: A Randomised, Double-Blind, Phase 3 Trial

Cited by 3 publications

References 22 publications

Tixagevimab + Cilgavimab: First Approval

Tixagevimab + Cilgavimab: First Approval

The effect of tixagevimab-cilgavimab on clinical outcomes in patients with COVID-19: A systematic review with meta-analysis

Puesta en marcha de una unidad COVID de alto riesgo. La experiencia de un hospital general

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