Remdesivir is Effective for Moderately Severe Patients: A Re-Analysis of the First Double-Blind, Placebo-Controlled, Randomized Trial on Remdesivir for Treatment of Severe COVID-19 Patients Conducted in Wuhan City

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Open Access Journal of Clinical Trials Pub Date : 2020-07-30 DOI:10.2147/oajct.s262606
W. Shih, Xin Shen, Peng Zhang, Tai Xie
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引用次数: 7

Abstract

Introduction: The first clinical trial on remdesivir for treatment of severe COVID-19 conducted in China was terminated prematurely due to limited patient enrollment, which rendered the findings inconclusive. We re-analyzed the efficacy with a statistically more powerful and clinically meaningful method based on published data using the 6-point ordinal scale of patient’s disease severity. Methods: We defined response as patient’s point reached, either 2 (hospitalized, no require-ment for supplementary oxygen therapy) or 1 (discharged or met discharge criterion), and then analyzed with logistic regression with baseline score, day of assessment, treatment group, baseline by treatment interaction, and day by treatment interaction as covariates. The binary endpoint was supported by the recent FDA’s guidance on COVID-19. Results: Eighty-two percent (82%) of the patients were in the disease severity point=3 (hospitalized, required supplemental oxygen (but not NIV/HFNC)) – the moderately severe category. The response rate was 85% for remdesivir-treated patients with baseline disease point=3 versus 70% response rate for likewise placebo-treated patients on Day 28 (OR=2.38, P=0.0012). On Day 14, the response rate for these patients was 43% for remdesivir versus 33% for placebo (OR=1.53, P=0.0022). For patients with baseline disease point=4 (critically severe category), no similar comparisons were statistically significant. Conclusion and Discussion: The Chinese trial was not really under-powered as previously perceived or portrayed by many opinions. This result supports the preliminary findings of ACTT that remdesivir is effective for patients who were not critically severe. This result also suggests that remdesivir should be given to hospitalized COVID-19 patients as soon as possible. There is no race difference in the treatment effect.
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Remdesivir对中重度患者有效:对在武汉市进行的Remdesivire治疗重症新冠肺炎患者的首次双盲安慰剂对照随机试验的重新分析
中国首个使用瑞德西韦治疗重症COVID-19的临床试验因患者入组有限而提前终止,导致研究结果不确定。基于已发表的患者疾病严重程度的6点顺序量表,我们用一种统计上更有力、更有临床意义的方法重新分析了疗效。方法:我们将疗效定义为患者达到的积分,2分(住院,不需要补充氧治疗)或1分(出院或符合出院标准),然后以基线评分、评估日、治疗组、治疗相互作用基线和治疗相互作用日为协变量进行logistic回归分析。该双终点得到了最近FDA关于COVID-19的指导意见的支持。结果:82%(82%)的患者处于疾病严重程度点=3(住院,需要补充氧气(但不需要NIV/HFNC)) -中度重症类别。瑞德西韦治疗的基线疾病点=3的患者的缓解率为85%,而安慰剂治疗的患者在第28天的缓解率为70% (OR=2.38, P=0.0012)。在第14天,这些患者的反应率为瑞德西韦43%,安慰剂33% (OR=1.53, P=0.0022)。对于基线疾病点=4(危重类)的患者,相似比较无统计学意义。结论和讨论:中国的试验并不像之前许多观点所认为或所描绘的那样,真的是力量不足。这一结果支持了ACTT的初步发现,即瑞德西韦对非危重患者有效。这一结果也提示应尽快给予住院COVID-19患者瑞德西韦。治疗效果没有种族差异。
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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