Instituto de Cardiología de Corrientes, Bolivar 1334, Zip code, 3400, Corrientes, Argentina.
Epidemiology. Ministerio de Salud Pública de la Provincia de Corrientes, Corrientes, Argentina.
BMC Infect Dis. 2021 Jul 2;21(1):635. doi: 10.1186/s12879-021-06348-5.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients.
To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
DESIGN, SETTING AND PARTICIPANTS: A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021.
Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days.
The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points.
The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes.
Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes.
ClinicalTrials.gov NCT04529525 .
严重急性呼吸综合征冠状病毒 2（SARS-CoV2）改变了我们的生活。科学界一直在研究重新利用的治疗方法，以防止冠状病毒病（COVID-19）患者的病情恶化。
确定伊维菌素治疗是否可以预防 COVID-19 早期患者住院。
设计、地点和参与者：在阿根廷科连特斯的非住院 COVID-19 患者中进行了一项随机、双盲、安慰剂对照研究。在 SARS-CoV-2 鼻拭子阳性后的 48 小时内，通过电话联系患者邀请他们参加。该试验于 2020 年 8 月 19 日至 2021 年 2 月 22 日期间随机将 501 名患者分配至伊维菌素（N=250）或安慰剂（N=251）组。
根据患者的体重，患者以交错剂量随机分配至伊维菌素（N=250）或安慰剂（N=251）组，连续 2 天。
评估伊维菌素预防住院的疗效作为主要结果。我们评估了与安全性和其他疗效终点相关的次要结果。
平均年龄为 42 岁（SD±15.5），从症状发作到纳入的中位时间为 4 天[四分位距 3-6]。伊维菌素组有 14/250（5.6%）的患者发生住院治疗的主要结局，安慰剂组有 21/251（8.4%）的患者发生（比值比 0.65；95%置信区间，0.32-1.31；p=0.227）。组间住院时间无统计学差异。从研究入组到侵入性机械通气支持（MVS）的平均时间为伊维菌素组 5.25 天（SD±1.71），安慰剂组 10 天（SD±2）（p=0.019）。其他次要结局，包括聚合酶链反应检测阴性和安全性结局，均无统计学差异。
住院事件发生率低、伊维菌素剂量和未纳入高危人群。
伊维菌素对预防 COVID-19 患者住院无显著影响。接受伊维菌素治疗的患者在治疗早期需要侵入性 MVS。其他次要结局均无显著差异。
ClinicalTrials.gov NCT04529525。
