Efficacy of Quinine Sulfate in Patients with Mild-To-Moderate COVID-19: A Randomized Controlled Trial

Irma Rahayu Latarissa, M. Barliana, A. Meiliana, Ida Paulina Sormin, Erizal Sugiono, Cissy Bana Kartasasmita, Irmansyah Irmansyah, Keri Lestari
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Abstract

BACKGROUND: Before WHO revoked the emergency use authorization for Chloroquine (CQ) and Hydroxychloroquine (HCQ) because of their side effects, it was suggested to use these two drugs for COVID-19 therapy. In addition, another derivate of quinine, namely Quinine Sulfate (QS), showed good in silico and in vitro antiviral activity against SARS-CoV-2. Prior the WHO revocation, this study was conducted to evaluate the efficacy of QS in mild-to-moderate COVID-19 patients.METHODS: This was an adaptive, controlled, multicenter, randomized, double-blind clinical trial involving mild-to-moderate COVID-19 patients in Indonesia. The participants were divided into 2 groups: the control group (standard COVID-19 treatment + placebo) and the treatment group (standard COVID-19 treatment + QS). The primary outcome was the efficacy of QS based on clinical status using a 7-point ordinal scale. The secondary outcomes were the efficacy of QS in terms of the incidence and duration of oxygen supplementation, incidence of mechanical ventilation, and length of stay.RESULTS: No significant difference in the efficacy parameters studied was found between the control group and the treatment group. The difference in the mean oxygen saturation was also measured and the results showed a significant difference where the treatment group had higher mean oxygen saturation than the control group (p=0.001).CONCLUSION: Although not significant, the treatment group showed better therapy outcomes compared to the control group.KEYWORDS: clinical trials, efficacy, quinine, chloroquine, hydroxychloroquine
硫酸奎宁对轻度至中度 COVID-19 患者的疗效:随机对照试验
背景:在世界卫生组织因氯喹(CQ)和羟氯喹(HCQ)的副作用而撤销这两种药物的紧急使用授权之前,曾建议将这两种药物用于 COVID-19 的治疗。此外,奎宁的另一种衍生物,即硫酸奎宁(Quinine Sulfate,QS)对 SARS-CoV-2 显示出良好的体内和体外抗病毒活性。方法:这是一项适应性、对照、多中心、随机、双盲临床试验,涉及印度尼西亚的轻度至中度 COVID-19 患者。参与者分为两组:对照组(标准 COVID-19 治疗+安慰剂)和治疗组(标准 COVID-19 治疗+QS)。主要结果是QS的疗效,根据临床状态采用7点序数量表。结果:对照组和治疗组的疗效参数无显著差异。结论:尽管差异不明显,但治疗组与对照组相比显示出更好的治疗效果。关键词:临床试验,疗效,奎宁,氯喹,羟氯喹
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