Clinical Infectious Diseases

, том 76 , издание 7

AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19

Myron J. Levin ¹

Andrew Ustianowski ²

Steven Thomas ³

Alison Templeton ⁴

Yuan Yuan ³

Seth Seegobin ⁴

Catherine F. Houlihan ^{5, 6}

Ibrahim Menendez Perez ⁷

Simon Pollett ^{8, 9}

Rosalinda H. Arends ¹⁰

Rohini Beavon ¹¹

Kanika Dey ¹²

Pedro Garbes ¹²

Elizabeth J. Kelly ¹³

Gavin C K W Koh ¹¹

STEFAN IVANOV ¹⁴

Karen A. Near ¹²

Audrey Sharbaugh ¹⁵

Katie Streicher ¹³

Menelas N. Pangalos ¹⁶

Mark T Esser ¹⁷

Скрыть аффилиации авторов Показать аффилиации авторов: 17 аффилиаций

University of Colorado Denver School of Medicine , Aurora, Colorado , USA |

North Manchester General Hospital , Manchester , United Kingdom |

Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA |

⁴

Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom |

⁵

Department of Clinical Virology, University College London Hospitals National Health Service Foundation Trust , London , United Kingdom |

⁶

Department of Infection and Immunity, University College London , London , United Kingdom |

⁷

Project 4 Research , Miami, Florida , USA |

⁸

Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences , Bethesda, Maryland , USA |

⁹

Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc , Bethesda, Maryland , USA |

¹⁰

Clinical Pharmacology and Quantitative Pharmacology, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA |

¹¹

Clinical Development, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom |

¹²

Clinical Development, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA |

¹³

Translational Medicine, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA |

¹⁴

Clinical Development, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gothenburg , Sweden |

¹⁵

Clinical Development, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Durham, North Carolina , USA |

¹⁶

BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom |

¹⁷

Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA |

Тип публикации: Journal Article

Дата публикации: 2022-11-22

Oxford University Press

Clinical Infectious Diseases

scimago Q1

wos Q1

БС1

SJR: 2.992

CiteScore: 21.0

Impact factor: 7.3

ISSN: 10584838, 15376591

DOI: 10.1093/cid/ciac899

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PubMed ID: 36411267

Краткое описание

Background

We report primary results of a phase 3 trial of AZD7442 (tixagevimab/cilgavimab) for post-exposure prophylaxis to prevent symptomatic coronavirus disease 2019 (COVID-19)

Methods

Adults without prior SARS-CoV-2 infection or COVID-19 vaccination were enrolled within 8 days of exposure to a SARS-CoV-2–infected individual and randomized 2:1 to a single 300-mg AZD7442 dose (one 1.5-mL intramuscular injection each of tixagevimab and cilgavimab consecutively) or placebo. Primary endpoints were safety and first post-dose SARS-CoV-2 reverse-transcription–polymerase-chain-reaction (RT-PCR)–positive symptomatic COVID-19 event before day 183.

Results

1121 participants were randomized and dosed (mean age 46 years; 49% females; AZD7442, n=749; placebo, n=372). Median (range) follow-up was 49 (5–115) and 48 (20–113) days for AZD7442 and placebo, respectively. Adverse events occurred in 162/749 (21.6%) and 111/372 (29.8%) participants with AZD7442 and placebo, respectively, mostly mild/moderate. RT-PCR–positive symptomatic COVID-19 occurred in 23/749 (3.1%) and 17/372 (4.6%) AZD7442- and placebo-treated participants, respectively (relative risk reduction 33.3%; 95% confidence interval [CI] –25.9 to 64.7; P=.21). In predefined subgroup analyses of 1073 (96%) participants who were SARS-CoV-2 RT-PCR–negative (n=974 [87%]) or missing an RT-PCR result (n=99 [9%]) at baseline, AZD7442 reduced RT-PCR–positive symptomatic COVID-19 by 73.2% (95% CI 27.1 to 90.1) versus placebo.

Conclusions

This study did not meet the primary efficacy endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 versus placebo. However, predefined analysis of participants who were SARS-CoV-2 RT-PCR–negative or missing an RT-PCR result at baseline support a role for AZD7442 in preventing symptomatic COVID-19.

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Levin M. J. et al. AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19 // Clinical Infectious Diseases. 2022. Vol. 76. No. 7.

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Levin M. J., Ustianowski A., Thomas S., Templeton A., Yuan Y., Seegobin S., Houlihan C. F., Menendez Perez I., Pollett S., Arends R. H., Beavon R., Dey K., Garbes P., Kelly E. J., Koh G. C. K. W., IVANOV S., Near K. A., Sharbaugh A., Streicher K., Pangalos M. N., Esser M. T. AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19 // Clinical Infectious Diseases. 2022. Vol. 76. No. 7.

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TY - JOUR

DO - 10.1093/cid/ciac899

UR - https://doi.org/10.1093/cid/ciac899

TI - AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19

T2 - Clinical Infectious Diseases

AU - Levin, Myron J.

AU - Ustianowski, Andrew

AU - Thomas, Steven

AU - Templeton, Alison

AU - Yuan, Yuan

AU - Seegobin, Seth

AU - Houlihan, Catherine F.

AU - Menendez Perez, Ibrahim

AU - Pollett, Simon

AU - Arends, Rosalinda H.

AU - Beavon, Rohini

AU - Dey, Kanika

AU - Garbes, Pedro

AU - Kelly, Elizabeth J.

AU - Koh, Gavin C K W

AU - IVANOV, STEFAN

AU - Near, Karen A.

AU - Sharbaugh, Audrey

AU - Streicher, Katie

AU - Pangalos, Menelas N.

AU - Esser, Mark T

PY - 2022

DA - 2022/11/22

PB - Oxford University Press

IS - 7

VL - 76

PMID - 36411267

SN - 1058-4838

SN - 1537-6591

ER -

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@article{2022_Levin,

author = {Myron J. Levin and Andrew Ustianowski and Steven Thomas and Alison Templeton and Yuan Yuan and Seth Seegobin and Catherine F. Houlihan and Ibrahim Menendez Perez and Simon Pollett and Rosalinda H. Arends and Rohini Beavon and Kanika Dey and Pedro Garbes and Elizabeth J. Kelly and Gavin C K W Koh and STEFAN IVANOV and Karen A. Near and Audrey Sharbaugh and Katie Streicher and Menelas N. Pangalos and Mark T Esser},

title = {AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19},

journal = {Clinical Infectious Diseases},

year = {2022},

volume = {76},

publisher = {Oxford University Press},

month = {nov},

url = {https://doi.org/10.1093/cid/ciac899},

number = {7},

doi = {10.1093/cid/ciac899}

}

Издатель

Oxford University Press

Журнал

Clinical Infectious Diseases

scimago Q1

wos Q1

БС1

SJR

2.992

CiteScore

21.0

Impact factor

7.3

ISSN

10584838 (Print)

15376591 (Electronic)