哥伦比亚儿科感染学研究中心Eduardo López-Medina团队研究了伊维菌素治疗轻度COVID-19成人对症状缓解时间的影响。2021年3月4日，该研究发表在《美国医学会杂志》上。

伊维菌素作为COVID-19的一种潜在治疗方法被广泛应用，尽管其临床疗效尚不确定。

为了确定伊维菌素治疗轻度COVID-19是否有效，研究组在哥伦比亚卡利的一个机构进行了一项双盲随机试验。从国家卫生部招募有症状的、实验室确诊的COVID-19患者，2020年7月15日至11月30日，共招募了476名患有7天或更短时间（在家或住院）轻度疾病和症状的成年患者，随访至2020年12月21日。将患者随机分组，其中200例接受伊维菌素治疗，连续5天，200例接受安慰剂治疗。主要结局为在21天的随访期内症状消失的时间，分析治疗过程中的不良事件。

400名患者的中位年龄为37岁，女性占58%，398名（99.5%）完成了试验。伊维菌素组症状缓解的中位时间为10天，安慰剂组症状缓解的中位时间为12天，差异不显著。到第21天，伊维菌素组中82%和安慰剂组中79%的患者症状缓解。最常见的不良反应是头痛，伊维菌素组中有104名患者（52%），安慰剂组中有111名患者（56%）。最常见的严重不良事件是多器官衰竭，共有4例（每组2例）。

研究结果表明，对于轻度COVID-19的成人，与安慰剂相比，伊维菌素治疗5天并没有显著缩短症状缓解的时间。

附：英文原文

Title: Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial

Author: Eduardo López-Medina, Pío López, Isabel C. Hurtado, Diana M Dávalos, Oscar Ramirez, Ernesto Martínez, Jesus A. Díazgranados, José M. Oate, Hector Chavarriaga, Sócrates Herrera, Beatriz Parra, Gerardo Libreros, Roberto Jaramillo, Ana C. Avendao, Dilian F. Toro, Miyerlandi Torres, Maria C. Lesmes, Carlos A. Rios, Isabella Caicedo

Issue&Volume: 2021-03-04

Abstract:

Importance  Ivermectin is widely prescribed as a potential treatment for COVID-19 despite uncertainty about its clinical benefit.

Objective  To determine whether ivermectin is an efficacious treatment for mild COVID-19.

Design, Setting, and Participants  Double-blind, randomized trial conducted at a single site in Cali, Colombia. Potential study participants were identified by simple random sampling from the state’s health department electronic database of patients with symptomatic, laboratory-confirmed COVID-19 during the study period. A total of 476 adult patients with mild disease and symptoms for 7 days or fewer (at home or hospitalized) were enrolled between July 15 and November 30, 2020, and followed up through December 21, 2020.

Intervention  Patients were randomized to receive ivermectin, 300 μg/kg of body weight per day for 5 days (n=200) or placebo (n=200).

Main Outcomes and Measures  Primary outcome was time to resolution of symptoms within a 21-day follow-up period. Solicited adverse events and serious adverse events were also collected.

Results  Among 400 patients who were randomized in the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the trial. The median time to resolution of symptoms was 10 days (IQR, 9-13) in the ivermectin group compared with 12 days (IQR, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95% CI, 0.87 to 1.32]; P=.53 by log-rank test). By day 21, 82% in the ivermectin group and 79% in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo. The most common serious adverse event was multiorgan failure, occurring in 4 patients (2 in each group).

Conclusion and Relevance  Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes.

DOI: 10.1001/jama.2021.3071

Source: https://jamanetwork.com/journals/jama/fullarticle/2777389