Clinical Infectious Diseases

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
1
 
University of Colorado Denver School of Medicine , Aurora, Colorado , USA
2
 
North Manchester General Hospital , Manchester , United Kingdom
3
 
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
7
 
Project 4 Research , Miami, Florida , 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
Publication typeJournal Article
Publication date2022-11-22
Quartile SCImago
Q1
Quartile WOS
Q1
Impact factor11.8
ISSN10584838, 15376591
Abstract
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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GOST Copy
Levin M. J. et al. AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19 // Clinical Infectious Diseases. 2022.
GOST all authors (up to 50) Copy
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.
RIS |
Cite this
RIS Copy
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 00:00:00
PB - Oxford University Press
SN - 1058-4838
SN - 1537-6591
ER -
BibTex
Cite this
BibTex Copy
@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},
publisher = {Oxford University Press},
month = {nov},
url = {https://doi.org/10.1093/cid/ciac899},
doi = {10.1093/cid/ciac899}
}
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