Jang Young Rock, Oh Yoon Ju, Kim Jin Yong
Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Center, Incheon, Republic of Korea.
Division of Metabolism and Endocrinology, Department of Internal Medicine, Incheon Medical Center, Incheon, Republic of Korea.
Curr Ther Res Clin Exp. 2022;96:100675. doi: 10.1016/j.curtheres.2022.100675. Epub 2022 May 16.
In a Phase III study, regdanvimab (CT-P59) reduced the risk of hospitalization or death versus placebo in patients with mild-to-moderate coronavirus disease 2019 (COVID-19).
We performed a retrospective cohort study of patients with COVID-19 to examine the effect of regdanvimab versus standard of care (SoC) on oxygen saturation.
We reviewed patients with mild-to-moderate COVID-19 confirmed by reverse transcription-polymerase chain reaction at a single hospital in the Republic of Korea. The primary efficacy end point was the proportion of patients deteriorating with peripheral capillary oxygen saturation <94% on room air up to day 28.
A total of 127 patients were treated for COVID-19 with regdanvimab, 190 with SoC. The proportion of patients deteriorating with peripheral capillary oxygen saturation <94% on room air up to day 28 was 13.4% with regdanvimab and 39.5% with SoC ( 0.0001); median time (range) until sustained recovery of fever was 2.0 (0.2-14.8) and 4.2 (0.1-17.1) days, respectively. Supplemental oxygen was required by 23.6% of patients with regdanvimab and 52.1% with SoC (0.0001) for a mean of 6.3 and 8.7 days, respectively ( 0.0113); no patients needed mechanical ventilation. Compared with SoC, hospitalization was shorter with regdanvimab (mean = 11.1 vs 13.6 days; 63.8% vs 31.6% discharged within 11 days; both values 0.0001). Fewer regdanvimab-treated patients required remdesivir (14.2% vs 43.2%; 0.0001). There were no deaths. Two patients had adverse reactions with regdanvimab.
This real-world study indicates that regdanvimab can prevent deterioration in patients with mild-to-moderate COVID-19. (. 2022; 83:XXX-XXX).
在一项III期研究中，与安慰剂相比，雷格丹维单抗（CT-P59）降低了2019冠状病毒病（COVID-19）轻至中度患者的住院或死亡风险。
我们对COVID-19患者进行了一项回顾性队列研究，以检验雷格丹维单抗与标准治疗（SoC）对血氧饱和度的影响。
我们回顾了韩国一家医院通过逆转录-聚合酶链反应确诊的轻至中度COVID-19患者。主要疗效终点是在第28天末室内空气中外周毛细血管血氧饱和度<94%的病情恶化患者比例。
共有127例COVID-19患者接受雷格丹维单抗治疗，190例接受标准治疗。在第28天末室内空气中外周毛细血管血氧饱和度<94%的病情恶化患者比例，雷格丹维单抗组为13.4%，标准治疗组为39.5%（<0.0001）；发热持续恢复的中位时间（范围）分别为2.0（0.2-14.8）天和4.2（0.1-17.1）天。雷格丹维单抗组23.6%的患者需要补充氧气，标准治疗组为52.1%（<0.0001），平均分别为6.3天和8.7天（<0.0113）；无患者需要机械通气。与标准治疗相比，雷格丹维单抗治疗的患者住院时间更短（平均=11.1天对13.6天；63.8%对31.6%在11天内出院；两者P值均<0.0001）。接受雷格丹维单抗治疗的患者中需要瑞德西韦的更少（14.2%对43.2%；<0.0001）。无死亡病例。两名患者出现了与雷格丹维单抗相关的不良反应。
这项真实世界研究表明，雷格丹维单抗可预防轻至中度COVID-19患者病情恶化。（.2022；83：XXX-XXX）
