Effect of tixagevimab/cilgavimab for pre-exposure prophylaxis during the China Omicron outbreak

ABSTRACT

Objectives

By the end of 2022, China had made a pivotal decision to optimize the COVID-19 policy. The dominant Omicron variant in China at that time was highly transmissible. In this study, we aimed to evaluate the real-world safety and efficacy of tixagevimab and cilgavimab against this background in China.

Methods

Participants were enrolled if they were over 12 years old and were planning to receive tixagevimab or cilgavimab. All participants received intramuscular administration of tixagevimab (150 mg) and cilgavimab (150 mg). Data were collected on demographics, underlying illness, prior infection, vaccination, adverse events, and COVID-19 outcomes (e.g., infection rate, hospitalization rate, and severe disease).

Results

During the study period, 168 (37.9%) of 443 who received tixagevimab/cilgavimab were diagnosed with SARS-CoV-2 infection. All infected patients had mild COVID-19. Two patients (0.5%) were hospitalized for COVID-19, but none of them were admitted to the ICU. None of the patients died during this study. 4 (0.9%) reported mild local adverse events, and no severe systemic adverse reactions were reported.

Conclusion

Tixagevimab/cilgavimab may have protected high-risk populations against infection with the Omicron variant, hospitalization and severe disease during the China COVID-19 pandemic.

KEYWORDS:

• COVID-19
• Omicron
• monoclonal antibodies
• tixagevimab-cilgavimab
• SARS-CoV-2

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Throughout the study, we have received a great deal of support and assistance from the Innovative research team of high-level local universities in Shanghai.

Author contributions

Min Zhou, Zhidong Gu, and Jieming Qu conceived the idea; Jianhua You and Jiaxin Tian performed the research and analyzed the data; Haidi Wu, Wenyan Kang, Jianru Wen, Hongwei Xu, Wenbo Shi, Zhi Wang, Hanyu Wei, Yanjun Du, Xiang Li, and Guangyuan Mu helped to perform the research; Jiaxin Tian and Jianhua You wrote the manuscript; Min Zhou, Zhidong Gu, and Jieming Qu critically corrected the manuscript. All authors have read and agreed to the published version of the manuscript.

Data availability statement

All data supporting the findings of this study are available within the article or from the corresponding authors upon reasonable request without any restrictions. Source data are provided with this paper.

Additional information

Funding

This paper was supported by the Shanghai Science and Technology Committe Project (No. 20XD1402400).