Additional Professor and Head, Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India.
Postgraduate Trainee, Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India.
J Pharm Pharm Sci. 2021;24:343-350. doi: 10.18433/jpps32105.
There has been a growing interest in ivermectin ever since it was reported to have an in-vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This trial was conducted to test the efficacy of ivermectin in mild and moderate coronavirus disease 19 (COVID-19).
A double blind, parallel, randomised, placebo-controlled trial conducted among adult COVID-19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India. Enrolment was done between 1st August and 31st October 2020. On day 1 and 2 post enrolment, patients in the intervention arm received ivermectin 12 mg while the patients in the non-interventional arm received placebo tablets.
About one-fourth (23.6%) of the patients in the intervention arm and one-third (31.6%) in the placebo arm were tested reverse transcriptase polymerase chain reaction (RTPCR) negative for SARS-CoV-2 on 6th day. Although this difference was found to be statistically insignificant [rate ratio (RR): 0.8; 95% confidence interval (CI): 0.4-1.4; p=0.348]. All patients in the ivermectin group were successfully discharged. In comparison the same for the placebo group was observed to be 93%. This difference was found to be statistically significant (RR: 1.1; 95% CI; 1.0-1.2; p=0.045).
Inclusion of ivermectin in treatment regimen of mild to moderate COVID-19 patients could not be said with certainty based on our study results as it had shown only marginal benefit in successful discharge from the hospital with no other observed benefits.
自从有报道称伊维菌素具有抗严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的体外活性以来，人们对伊维菌素的兴趣日益浓厚。本试验旨在测试伊维菌素治疗轻度和中度 2019 冠状病毒病（COVID-19）的疗效。
这是一项在印度东部一家 COVID 专门的三级保健中心对轻度至中度疾病严重程度的成年 COVID-19 患者进行的双盲、平行、随机、安慰剂对照试验。招募工作于 2020 年 8 月 1 日至 10 月 31 日进行。在入组后的第 1 天和第 2 天，干预组的患者接受伊维菌素 12 毫克，而非干预组的患者接受安慰剂片剂。
干预组约四分之一（23.6%）的患者和安慰剂组的三分之一（31.6%）在第 6 天检测 SARS-CoV-2 逆转录酶聚合酶链反应（RT-PCR）为阴性。虽然这种差异在统计学上无显著意义[率比（RR）：0.8；95%置信区间（CI）：0.4-1.4；p=0.348]。所有接受伊维菌素治疗的患者均成功出院。相比之下，安慰剂组的出院率为 93%。这种差异在统计学上有显著意义（RR：1.1；95% CI；1.0-1.2；p=0.045）。
根据我们的研究结果，不能确定在轻度至中度 COVID-19 患者的治疗方案中加入伊维菌素是否有益，因为它仅显示出在从医院成功出院方面的边际获益，没有观察到其他益处。
