Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine, Hainan Bo'ao Research Hospital, Qionghai, 571473, Hainan, China.
Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Virol J. 2024 Oct 24;21(1):262. doi: 10.1186/s12985-024-02509-5.
This study aimed to investigate the real-world use and clinical outcomes of tixagevimab/cilgavimab in China during the Omicron outbreak in late 2022.
This observational, real-world study included patients who received tixagevimab/cilgavimab from July 9 to December 30, 2022, in Hainan, China. Here, we report the baseline and characteristics and interim analysis results of the clinical outcomes in those receiving at least one dose of tixagevimab/cilgavimab (300 mg) for pre-exposure prophylaxis.
Among 248 subjects who received tixagevimab/cilgavimab, 229 subjects were included in this analysis. Until March 28, 2023, the median follow-up was 95 days. The mean age of the subjects was 44.4 ± 15.9 years, 11.8% were ≥ 65 years, and 41.5% were male. Fifty-eight (25.3%) subjects had comorbidities, 16.2% subjects had key immune compromised conditions. Seventy-two (32.6%) patients had laboratory-confirmed SARS-CoV-2 infection and/or received healthcare within three months; 71/72 (98.6%) had mild disease, and one (1.4%) was moderate. No COVID-19-related intensive care unit (ICU) admissions, extracorporeal membrane oxygenation utilizations, or death occurred. Two (0.9%) patients required hospitalization. One (0.4%) serious adverse event occurred, which was considered unrelated to tixagevimab/cilgavimab.
Among Chinese patients receiving prophylactic tixagevimab/cilgavimab, the incidence of COVID-19-related hospitalization, ICU admission, or death was low during the Omicron surge. Further randomized controlled trials with larger sample sizes are needed to determine the effectiveness of tixagevimab/cilgavimab in preventing severe COVID-19 outcomes.
The study was registered with clinicaltrial.gov (NCT05917951).
本研究旨在调查 2022 年底奥密克戎流行期间替沙格韦单抗/西加韦单抗在中国的真实世界使用情况和临床结局。
这是一项观察性的真实世界研究，纳入 2022 年 7 月 9 日至 12 月 30 日期间在中国海南接受替沙格韦单抗/西加韦单抗治疗的患者。本研究报告了至少接受一剂替沙格韦单抗/西加韦单抗（300mg）进行暴露前预防的患者的基线和特征以及临床结局的中期分析结果。
在 248 例接受替沙格韦单抗/西加韦单抗治疗的患者中，229 例纳入本分析。截至 2023 年 3 月 28 日，中位随访时间为 95 天。患者的平均年龄为 44.4±15.9 岁，11.8%年龄≥65 岁，41.5%为男性。58 例（25.3%）患者合并基础疾病，16.2%患者存在关键免疫抑制情况。72 例（32.6%）患者发生实验室确诊的 SARS-CoV-2 感染和/或在三个月内接受医疗保健，71/72（98.6%）患者为轻症，1 例（1.4%）为中症。无 COVID-19 相关的重症监护病房（ICU）住院、体外膜氧合（ECMO）使用或死亡发生。2 例（0.9%）患者需要住院治疗。1 例（0.4%）发生严重不良事件，认为与替沙格韦单抗/西加韦单抗无关。
在接受预防性替沙格韦单抗/西加韦单抗治疗的中国患者中，在奥密克戎流行期间，COVID-19 相关住院、ICU 入院或死亡的发生率较低。需要更大样本量的随机对照试验来确定替沙格韦单抗/西加韦单抗在预防严重 COVID-19 结局方面的有效性。
本研究在 clinicaltrial.gov 注册（NCT05917951）。
