Background: Colchicine has been proposed as a potential therapy in coronavirus disease 2019 (COVID-19) due to their anti-inflammatory actions.
Methods: The COL-COVID study was a prospective, randomized, controlled and open-label clinical trial that compared colchicine added to standard treatment vs standard treatment in hospitalized COVID-19 patients that do not need mechanical ventilatory support. Colchicine was initiated within the first 48 hours of admission at a 1.5 mg loading dose, followed by 0.5 mg b.i.d. for one week and 0.5 mg per day for 28 days. The study endpoints were clinical status (7-points WHO ordinal scale) and inflammatory biomarkers (IL-6 and CRP).
Results: A total of 103 patients (51± 12 years, 52% male) were randomly allocated to colchicine arm (n=52) and control arm (n=51). At day 28, all patients in the colchicine group were alive and discharged, whereas in the control group, two patients died in-hospital and one patient remained hospitalized. Clinical improvement in terms of changes on WHO scale at day 14 and 28 and time to 1-point clinical improvement did not differ between the two groups. Clinical deterioration (increase of at least 1-point in WHO scale) was observed in a higher proportion of cases in colchicine group (13.8%) vs control group (5.8%) (p=0.303); after adjustment by baseline risk factors and concomitant therapies, colchicine therapy was associated with a lower risk of clinical deterioration (p=0.030). Inflammatory biomarkers CRP and IL-6 concentrations course did not differ between the two arms.
Conclusion: In hospitalized COVID-19 patients, colchicine treatment neither improved the clinical status, nor the inflammatory response, over the standard treatment. Nevertheless, a preventive effect for further clinical deterioration might be possible.
Trial Registration: NCT04350320.



中文翻译：

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秋水仙碱在最近住院的 COVID-19 患者中的作用：一项随机对照试验 (COL-COVID)


背景：秋水仙碱因其抗炎作用而被提议作为 2019 年冠状病毒病 (COVID-19) 的潜在疗法。

方法： COL-COVID 研究是一项前瞻性、随机、对照和开放标签的临床试验，比较了标准治疗中添加秋水仙碱与不需要机械通气支持的住院 COVID-19 患者的标准治疗。秋水仙碱在入院后 48 小时内开始服用 1.5 mg 负荷剂量，随后一周 0.5 mg bid，每天 0.5 mg，持续 28 天。研究终点是临床状态（7 点 WHO 顺序量表）和炎症生物标志物（IL-6 和 CRP）。

结果：共有 103 名患者（51±12 岁，52% 男性）被随机分配到秋水仙碱组 (n=52) 和对照组 (n=51)。第28天，秋水仙碱组的所有患者均存活并出院，而对照组有两名患者在院内死亡，一名患者仍在住院。就第 14 天和第 28 天的 WHO 量表变化以及达到 1 点临床改善的时间而言，两组之间的临床改善没有差异。与对照组 (5.8%) 相比，秋水仙碱组 (13.8%) 的病例比例较高 (p=0.303)；观察到临床恶化（世界卫生组织评分至少增加 1 分）；经过基线危险因素和伴随治疗调整后，秋水仙碱治疗与较低的临床恶化风险相关（p=0.030）。炎症生物标志物 CRP 和 IL-6 浓度过程在两组之间没有差异。

结论：在住院的 COVID-19 患者中，与标准治疗相比，秋水仙碱治疗既没有改善临床状态，也没有改善炎症反应。尽管如此，对临床进一步恶化的预防作用还是有可能的。

试用注册： NCT04350320。