Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.
Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, New Delhi, India.
J Infect Chemother. 2021 Dec;27(12):1743-1749. doi: 10.1016/j.jiac.2021.08.021. Epub 2021 Aug 25.
Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load. Hence, Ivermectin is under investigation as a repurposed agent for treating COVID-19.
In this pilot, double blind, randomized controlled trial, hospitalized patients with mild-to-moderate COVID-19 were assigned to a single oral administration of an elixir formulation of Ivermectin at either 24 mg or 12 mg dose, or placebo in a 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment. Safety outcomes included total and serious adverse events. The primary outcomes were assessed in patients who had positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes were assessed in all patients who received the intervention (intention-to-treat population).
Among the 157 patients randomized, 125 were included in modified intention-to-treat analysis. 40 patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg arm, 35.0%; and placebo arm, 31.1%; p-value = 0.30). The decline of viral load at day 5 was similar in each arm. No serious adverse events occurred.
In patients with mild and moderate COVID-19, a single oral administration of Ivermectin did not significantly increase either the negativity of RT-PCR or decline in viral load at day 5 of enrolment compared with placebo.
伊维菌素是一种抗寄生虫药物，具有体外降低严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）病毒载量的功效。因此，伊维菌素作为一种治疗 COVID-19 的药物正在被研究。
在这项双盲、随机对照的试点研究中，将患有轻度至中度 COVID-19 的住院患者按 1:1:1 的比例随机分为单次口服伊维菌素 24mg 或 12mg 剂量或安慰剂组。主要结局是 RT-PCR 转为阴性结果和登记第 5 天病毒载量下降。安全性结局包括总不良事件和严重不良事件。主要结局在登记时 RT-PCR 阳性的患者中评估（意向治疗人群）。安全性结局在接受干预的所有患者中评估（全分析集）。
在随机的 157 名患者中，125 名患者纳入意向治疗人群进行改良分析。每组 40 名患者分别接受伊维菌素 24mg 和 12mg 治疗，45 名患者接受安慰剂治疗。第 5 天 RT-PCR 阴性率在伊维菌素组较高，但未达到统计学意义（伊维菌素 24mg 组为 47.5%；12mg 组为 35.0%；安慰剂组为 31.1%；p 值=0.30）。第 5 天病毒载量下降在各组间相似。无严重不良事件发生。
在患有轻度和中度 COVID-19 的患者中，与安慰剂相比，单次口服伊维菌素并未显著增加 RT-PCR 阴性率或登记第 5 天的病毒载量下降。
