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非那韦利特治疗门诊 COVID-19:一项多中心、随机、三盲、安慰剂对照临床试验。

Favipiravir in the Treatment of Outpatient COVID-19: A Multicenter, Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

机构信息

Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan 8174673461, Iran.

Department of Internal Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan 8174673461, Iran.

出版信息

Adv Respir Med. 2023 Jan 28;91(1):18-25. doi: 10.3390/arm91010004.

DOI:10.3390/arm91010004
PMID:36825938
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9951951/
Abstract

BACKGROUND

Finding effective outpatient treatments to prevent COVID-19 progression and hospitalization is necessary and is helpful in managing limited hospital resources. Repurposing previously existing treatments is highly desirable. In this study, we evaluate the efficacy of Favipiravir in the prevention of hospitalization in symptomatic COVID-19 patients who were not eligible for hospitalization.

METHODS

This study was a triple-blind randomized controlled trial conducted between 5 December 2020 and 31 March 2021 in three outpatient centers in Isfahan, Iran. Patients in the intervention group received Favipiravir 1600 mg daily for five days, and the control group received a placebo. Our primary outcome was the proportion of hospitalized participants from day 0 to day 28. The outcome was assessed on days 3, 7, 14, 21, and 28 through phone calls.

RESULTS

Seventy-seven patients were randomly allocated to Favipiravir and placebo groups. There was no significant difference between groups considering baseline characteristics. During the study period, 10.5% of patients in the Favipiravir group and 5.1% of patients in the placebo group were hospitalized, but there was no significant difference between them (-value = 0.3). No adverse event was reported in the treatment group.

CONCLUSIONS

Our study shows that Favipiravir did not reduce the hospitalization rate of mild to moderate COVID-19 patients in outpatient settings.

摘要

背景

寻找有效的门诊治疗方法来预防 COVID-19 进展和住院是必要的,有助于管理有限的医院资源。重新利用以前存在的治疗方法是非常可取的。在这项研究中,我们评估了法匹拉韦在预防不符合住院条件的有症状 COVID-19 患者住院方面的疗效。

方法

这是一项于 2020 年 12 月 5 日至 2021 年 3 月 31 日在伊朗伊斯法罕的三个门诊中心进行的三盲随机对照试验。干预组患者每天接受法匹拉韦 1600mg,连续 5 天,对照组患者接受安慰剂。我们的主要结局是从第 0 天到第 28 天住院参与者的比例。通过电话在第 3、7、14、21 和 28 天评估结果。

结果

77 名患者被随机分配到法匹拉韦组和安慰剂组。考虑到基线特征,两组之间没有显著差异。在研究期间,法匹拉韦组 10.5%的患者和安慰剂组 5.1%的患者住院,但两组之间无显著差异(-值=0.3)。治疗组未报告不良事件。

结论

我们的研究表明,法匹拉韦并不能降低门诊轻中度 COVID-19 患者的住院率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9608/9951951/3272e9e4b9ba/arm-91-00004-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9608/9951951/27e683d3ddf8/arm-91-00004-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9608/9951951/3272e9e4b9ba/arm-91-00004-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9608/9951951/27e683d3ddf8/arm-91-00004-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9608/9951951/3272e9e4b9ba/arm-91-00004-g002.jpg

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