在一项随机安慰剂对照试验中，抗严重急性呼吸综合征冠状病毒2单克隆抗体治疗后的病毒和症状反弹
Viral and Symptom Rebound Following Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial.
作者信息
Chew Kara W, McGinley Brooke, Moser Carlee, Li Jonathan Z, Evering Teresa H, Ritz Justin, Javan Arzhang Cyrus, Margolis David, Wohl David A, Hughes Michael D, Daar Eric S, Currier Judith S, Eron Joseph J, Smith Davey M
机构信息
Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA.
出版信息
J Infect Dis. 2025 Feb 4;231(1):131-136. doi: 10.1093/infdis/jiae501.
We explored viral and symptom rebound after coronavirus disease 2019 amubarvimab-romlusevimab monoclonal antibody therapy versus placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal severe acute respiratory syndrome coronavirus 2 polymerase chain reaction testing at study days 3, 7, 14, and 28. Viral rebound was defined as RNA ≥3 and ≥0.5 log10 copies/mL increase from day 3 or 7, and symptom rebound as hospitalization or any moderate/severe symptom for ≥2 days after initial symptom improvement. There was no difference in viral rebound (∼5%/arm) (analysis population n = 713) or symptom rebound among participants who initially improved (hazard ratio, 0.95 [95% confidence interval, .52-1.75]; analysis population n = 574); <1% had both viral/symptom rebound.
在随机对照的ACTIV-2/A5401试验中，我们探讨了2019冠状病毒病接受安巴韦单抗-罗米司韦单抗单克隆抗体治疗与接受安慰剂治疗后的病毒反弹和症状反弹情况。参与者在研究第3、7、14和28天接受了鼻拭子严重急性呼吸综合征冠状病毒2聚合酶链反应检测。病毒反弹定义为自第3天或第7天起RNA增加≥3且≥0.5 log10拷贝/mL，症状反弹定义为在初始症状改善后住院或出现任何中度/重度症状≥2天。在最初症状改善的参与者中，病毒反弹（每组约5%）（分析人群n = 713）或症状反弹无差异（风险比，0.95 [95%置信区间，0.52 - 1.75]；分析人群n = 574）；<1%的参与者同时出现病毒/症状反弹。
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