Yale University School of Medicine, New Haven, CT, United States of America; Yale New Haven Health System, CT, United States of America.
Yale New Haven Health System, CT, United States of America; Greenwich Hospital, Greenwich, CT, United States of America.
Contemp Clin Trials. 2021 Nov;110:106547. doi: 10.1016/j.cct.2021.106547. Epub 2021 Aug 28.
Despite improvement in the standard of care (SOC) for hospitalized COVID-19 patients, rates of morbidity and mortality remain high. There continues to be a need for easily available and cost-effective treatments. Colchicine and rosuvastatin are both safe and well-studied medications with anti-inflammatory and other pleiotropic effects that may provide additional benefits to hospitalized COVID-19 patients.
The Colchicine/Statin for the Prevention of COVID-19 Complications (COLSTAT) trial is a pragmatic, open-label, multicenter, randomized trial comparing the combination of colchicine and rosuvastatin in addition to SOC to SOC alone in hospitalized COVID-19 patients. Four centers in the Yale New Haven Health network will enroll a total of 466 patients with 1:1 randomization. The trial will utilize the electronic health record (Epic® Systems, Verona, Wisconsin, USA) at all stages including screening, randomization, intervention, event ascertainment, and follow-up. The primary endpoint is the 30-day composite of progression to severe COVID-19 disease as defined by the World Health Organization ordinal scale of clinical improvement and arterial/venous thromboembolic events. The secondary powered endpoint is the 30-day composite of death, respiratory failure requiring intubation, and myocardial injury.
The COLSTAT trial will provide evidence on the efficacy of repurposing colchicine and rosuvastatin for the treatment of hospitalized COVID-19 patients. Moreover, it is designed to be a pragmatic trial that will demonstrate the power of using electronic health records to improve efficiency and enrollment in clinical trials in an adapting landscape.
NCT04472611 (https://clinicaltrials.gov/ct2/show/NCT04472611).
尽管住院 COVID-19 患者的治疗标准（SOC）有所提高，但发病率和死亡率仍然很高。仍然需要易于获得且具有成本效益的治疗方法。秋水仙碱和瑞舒伐他汀都是安全且经过充分研究的药物，具有抗炎和其他多效性作用，可能为住院 COVID-19 患者提供额外的益处。
秋水仙碱/他汀类药物预防 COVID-19 并发症（COLSTAT）试验是一项实用的、开放标签、多中心、随机试验，比较了秋水仙碱和瑞舒伐他汀联合 SOC 与 SOC 单独治疗住院 COVID-19 患者的疗效。耶鲁纽黑文健康网络的 4 个中心将总共招募 466 名患者，进行 1:1 随机分组。该试验将在包括筛查、随机分组、干预、事件确定和随访在内的所有阶段利用电子病历（Epic® Systems，威斯康星州 Verona，美国）。主要终点是 30 天内按世界卫生组织临床改善等级量表定义的严重 COVID-19 疾病进展和动静脉血栓栓塞事件的复合终点。次要的有影响力的终点是 30 天内死亡、需要插管的呼吸衰竭和心肌损伤的复合终点。
COLSTAT 试验将提供关于重新利用秋水仙碱和瑞舒伐他汀治疗住院 COVID-19 患者的疗效的证据。此外，它旨在成为一项实用试验，将展示利用电子病历提高临床试验效率和招募的能力，以适应不断变化的环境。
NCT04472611（https://clinicaltrials.gov/ct2/show/NCT04472611）。
