Efficacy and safety of a novel antiviral herbal preparation in ICU-admitted patients with COVID-19: A phase III double-blinded controlled trial.

IF 1.9 Q3 CHEMISTRY, MEDICINAL
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引用次数: 0

Abstract

Objective: Despite an increasing number of studies, there is as yet no definite treatment developed for the coronavirus disease 2019 (COVID-19). In this clinical trial, we examined the efficacy of a novel herbal antiviral preparation in critically ill COVID-19 patients.

Materials and methods: A total number of 120 ICU-admitted patients with a diagnosis of COVID-19 pneumonia were recruited to the trial. Participants were equally randomized to receive either the novel antiviral preparation sublingually, for up to two consecutive weeks or till discharge, or placebo. Clinical and laboratory parameters as well as survival rates were compared between the two groups.

Results: The cumulative incidence of death throughout the study period was 8.33% in the intervention group and 60% in the placebo group (risk ratio: 0.14; 95% confidence interval [CI], 0.05 to 0.32; p<0.001). On day 7, several parameters including white blood cells (WBCs) count, C-reactive protein, and SpO2 were improved for the treatment group compared with the placebo group (p-values of 0.05, 0.01, and <0.001, respectively).

Conclusion: This preparation might be suggested as a potentially promising COVID-19 treatment.

新型抗病毒草药制剂对入住ICU的COVID-19患者的疗效和安全性:III期双盲对照试验。
目的:尽管研究越来越多,但目前还没有针对2019年冠状病毒病(COVID-19)的明确治疗方法。在这项临床试验中,我们研究了一种新型草药抗病毒制剂对 COVID-19 重症患者的疗效:试验共招募了 120 名确诊为 COVID-19 肺炎的 ICU 入院患者。参与者被随机分配到舌下含服新型抗病毒制剂或安慰剂,前者最长可连续含服两周或直至出院,后者最长可连续含服两周或直至出院。对两组患者的临床和实验室指标以及存活率进行了比较:结果:在整个研究期间,干预组的累计死亡发生率为 8.33%,安慰剂组为 60%(风险比:0.14;95% 置信区间 [CI],0.05 至 0.32;P2);与安慰剂组相比,治疗组的生存率有所提高(P 值分别为 0.05、0.01 和 0.01):该制剂可作为一种有潜力的 COVID-19 治疗方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Avicenna Journal of Phytomedicine
Avicenna Journal of Phytomedicine CHEMISTRY, MEDICINAL-
CiteScore
3.40
自引率
4.50%
发文量
17
审稿时长
6 weeks
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