From the Department of Ophthalmology, Bingham University, Karu/Jos, Nassarawa/Plateau state, Nigeria.
Department of Surgery, College of Medicine and Lagos University Teaching Hospital, Lagos, Nigeria.
QJM. 2022 Jan 5;114(11):780-788. doi: 10.1093/qjmed/hcab035.
In vitro studies have shown the efficacy of Ivermectin (IV) to inhibit the SARS-CoV-2 viral replication, but questions remained as to in-vivo applications. We set out to explore the efficacy and safety of Ivermectin in persons infected with COVID19.
We conducted a translational proof of concept randomized, double blind placebo controlled, dose response and parallel group study of IV efficacy in RT-polymerase chain reaction proven COVID 19 positive patients. Sixty-two patients were randomized to three treatment groups. (A) IV 6 mg regime, (B) IV 12 mg regime (given Q84 h for 2 weeks) (C, control) Lopinavir/Ritonavir. All groups plus standard of Care.
The Days to COVID negativity (DTN) was significantly and dose dependently reduced by IV (P = 0.0066). The DTN for Control were, = 9.1+/-5.2, for A 6.0 +/- 2.9 and for B 4.6 +/-3.2. Two way repeated measures ANOVA of ranked COVID 19 +/- scores at 0, 84, 168 and252h showed a significant IV treatment effect (P = 0.035) and time effect (P < 0.0001). IV also tended to increase SPO2% compared to controls, P = 0.073, 95% CI-0.39 to 2.59 and increased platelet count compared to C (P = 0.037) 95%CI 5.55-162.55 × 103/ml. The platelet count increase was inversely correlated to DTN (r = -0.52, P = 0.005). No SAE was reported.
12mg IV regime given twice a week may have superior efficacy over 6mg IV given twice a week, and certainly over the non IV arm of the study. IV should be considered for use in clinical management of SARS-COV2, and may find applications in prophylaxis in high risk areas.
体外研究表明伊维菌素（IV）能够抑制 SARS-CoV-2 病毒的复制，但体内应用仍存在疑问。我们旨在探索伊维菌素在感染 COVID19 的人群中的疗效和安全性。
我们进行了一项转化概念验证的随机、双盲、安慰剂对照、剂量反应和平行组研究，以评估 IV 在 RT-PCR 证实的 COVID-19 阳性患者中的疗效。62 名患者被随机分为三组治疗组。（A）IV 6mg 方案，（B）IV 12mg 方案（每 84 小时给予一次，共 2 周）（C，对照组）洛匹那韦/利托那韦。所有组均加用标准治疗。
COVID 阴性的天数（DTN）显著且剂量依赖性地降低（P=0.0066）。对照组的 DTN 为 9.1+/-5.2，A 组为 6.0+/-2.9，B 组为 4.6+/-3.2。0、84、168 和 252 小时时 COVID 19 +/-评分的双向重复测量方差分析显示 IV 治疗有显著效果（P=0.035）和时间效应（P<0.0001）。与对照组相比，IV 还倾向于增加 SpO2%，P=0.073，95%CI-0.39 至 2.59，与 C 相比，IV 还增加了血小板计数（P=0.037）95%CI 5.55-162.55×103/ml。血小板计数的增加与 DTN 呈负相关（r=-0.52，P=0.005）。未报告严重不良事件。
每周两次给予 12mg IV 方案可能比每周两次给予 6mg IV 方案更有效，当然也比研究中的非 IV 组更有效。IV 应考虑用于 SARS-COV2 的临床管理，并且可能在高风险地区的预防中找到应用。
