随机安慰剂对照试验中抗 SARS-CoV-2 单克隆抗体治疗后的病毒和症状反弹。

Kara W Chew,Brooke McGinley,Carlee Moser,Jonathan Z Li,Teresa H Evering,Justin Ritz,Arzhang Cyrus Javan,David Margolis,David A Wohl,Michael D Hughes,Eric S Daar,Judith S Currier,Joseph J Eron,Davey M Smith,
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摘要

在随机 ACTIV-2/A5401 试验中,我们探讨了 COVID-19 阿穆巴单抗/罗卢舍单抗单克隆抗体疗法与安慰剂对比后的病毒和症状反弹情况。参与者在研究第 3、7、14 和 28 天接受鼻腔 SARS-CoV-2 PCR 检测。病毒反弹的定义是 RNA 从第 3 天或第 7 天起增加≥3 和≥0.5 log10 copies/mL,症状反弹的定义是最初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(∼5%/臂)(分析人群 n=713)或症状反弹(危险比 0.95 (95% CI 0.52, 1.75, 分析人群) n=574)没有差异;同时出现病毒反弹/症状反弹的参与者不足 1%。
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Viral and symptom rebound following anti-SARS-CoV-2 monoclonal antibody therapy in a randomized placebo-controlled trial.
We explored viral and symptom rebound after COVID-19 amubarvimab/romlusevimab monoclonal antibody therapy vs placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal SARS-CoV-2 PCR 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% CI 0.52, 1.75, analysis population) n=574); <1% had both viral/symptom rebound.
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