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Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial)
medRxiv - Infectious Diseases Pub Date : 2020-07-08 , DOI: 10.1101/2020.07.07.20145979
Faiq I. Gorial; Sabeeh Mashhadani; Hend M Sayaly; Basim Dhawi Dakhil; Marwan M AlMashhadani; Adnan M Aljabory; , Hassan M Abbas; Mohammed Ghanim; Jawad I Rasheed

Background: To date no effective therapy has been demonstrated for COVID-19. In vitro, studies indicated that ivermectin (IVM) has antiviral effect. Objectives: To assess the effectiveness of ivermectin (IVM) as add-on therapy to hydroxychloroquine (HCQ) and azithromycin (AZT) in treatment of COVID-19. Methods: This Pilot clinical trial conducted on hospitalized adult patients with mild to moderate COVID-19 diagnosed according to WHO interim guidance. Sixteen Patients received a single dose of IVM 200Mcg /kg on admission day as add on therapy to hydroxychloroquine ( HCQ)and Azithromycin (AZT) and were compared with 71 controls received HCQ and AZT matched in age, gender, clinical features, and comorbidities. The primary outcome was percentage of cured patients, defined as symptoms free to be discharged from the hospital and 2 consecutive negative PCR test from nasopharyngeal swabs at least 24 hours apart. The secondary outcomes were time to cure in both groups and evaluated by measuring time from admission of the patient to the hospital till discharge. Results: Of 87 patients included in the study,t he mean age ± SD (range) of patients in the IVM group was similar to controls [44.87 ± 10.64 (28-60) vs 45.23 ± 18.47 (8-80) years, p=0.78] Majority of patients in both groups were male but statistically not significant [11(69%) versus 52 (73%), with male: female ratio 2.21 versus 2.7-, p=0.72) All the patients of IVM group were cured compared with the controls [ 16 (100 %) vs 69 (97.2 %)]. Two patients died in the controls. The mean time to stay in the hospital was significantly lower in IVM group compared with the controls (7.62 ±2.75 versus 13.22 ±.90 days, p=0.00005, effect size= 0.82). No adverse events were observed Conclusions : Add-on use of IVM to HCQ and AZT had better effectiveness, shorter hospital stay, and relatively safe compared with controls. however, a larger prospective study with longer follow up may be needed to validate these results.

中文翻译:

伊维菌素作为COVID-19管理中附加疗法的有效性(试行)

背景:迄今为止,尚未证明COVID-19的有效疗法。在体外,研究表明伊维菌素(IVM)具有抗病毒作用。目的:评估伊维菌素(IVM)作为羟氯喹(HCQ)和阿奇霉素(AZT)的联合治疗在治疗COVID-19中的有效性。方法:该初步临床试验针对根据WHO临时指南诊断为轻度至中度COVID-19的住院成人患者进行。十六名患者在入院当天接受单剂量IVM 200Mcg / kg作为羟氯喹(HCQ)和阿奇霉素(AZT)的补充治疗,并与71名接受了年龄,性别,临床特征和合并症相匹配的HCQ和AZT的对照组进行比较。主要结局是治愈的患者百分比,定义为可自医院排出的症状,并且至少连续24小时从鼻咽拭子连续两次进行阴性PCR测试。次要结果是两组的治愈时间,并通过测量从患者入院到出院的时间进行评估。结果:纳入研究的87位患者中,IVM组患者的平均年龄±SD(范围)与对照组相似[44.87±10.64(28-60)岁,相对于45.23±18.47(8-80)岁,p = 0.78]两组患者中多数为男性,但统计学上不显着[11(69%)对52(73%),男女比例为2.21对2.7-,p = 0.72)IVM组所有患者均已治愈与对照组相比[16(100%)vs 69(97.2%)]。两名患者在对照组中死亡。与对照组相比,IVM组的平均住院时间显着降低(7.62±2.75对13.22±.90天,p = 0.00005,效应量= 0.82)。结论:与对照组相比,在HCQ和AZT上附加使用IVM具有更好的疗效,更短的住院时间和相对安全的情况。但是,可能需要进行较大规模的前瞻性研究,并进行更长的随访,以验证这些结果。
更新日期:2020-07-08
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