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希腊研究科维德-19 并发症预防中的秋水仙碱作用(GRECCO-19 研究):原理和研究设计。

The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design.

机构信息

Medical School, National & Kapodistrian University of Athens, Athens, Greece.

Medical School, National & Kapodistrian University of Athens, Athens, Greece.

出版信息

Hellenic J Cardiol. 2020 Jan-Feb;61(1):42-45. doi: 10.1016/j.hjc.2020.03.002. Epub 2020 Apr 3.

Abstract

OBJECTIVE

Colchicine has been utilized safely in a variety of cardiovascular clinical conditions. Among its potential mechanisms of action is the non-selective inhibition of NLRP3 inflammasome which is thought to be a major pathophysiologic component in the clinical course of patients with COVID-19. GRECCO-19 will be a prospective, randomized, open-labeled, controlled study to assess the effects of colchicine in COVID-19 complications prevention.

METHODS

Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical picture that involves temperature >37.5 oC and at least two out of the: i. sustained coughing, ii. sustained throat pain, iii. Anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg will be included. Patients will be randomised (1:1) in colchicine or control group.

RESULTS

Trial results will be disseminated through peer-reviewed publications and conference presentations.

CONCLUSION

GRECCO-19 trial aims to identify whether colchicine may positively intervene in the clinical course of COVID-19. (ClinicalTrials.gov Identifier: NCT04326790).

摘要

目的

秋水仙碱已在多种心血管临床情况下安全使用。其潜在作用机制之一是非选择性抑制 NLRP3 炎性体,这被认为是 COVID-19 患者临床病程中的主要病理生理成分。GRECCO-19 将是一项前瞻性、随机、开放标签、对照研究,旨在评估秋水仙碱在 COVID-19 并发症预防中的作用。

方法

将纳入经实验室确证的 SARS-CoV-2 感染(RT-PCR 检测)且临床症状涉及体温 >37.5°C 且至少满足以下两种情况的患者:i. 持续咳嗽,ii. 持续咽喉疼痛,iii. 嗅觉丧失和/或味觉丧失,iv. 疲劳/乏力,v. PaO2<95 mmHg。患者将按照 1:1 的比例随机分配到秋水仙碱组或对照组。

结果

试验结果将通过同行评审的出版物和会议报告进行传播。

结论

GRECCO-19 试验旨在确定秋水仙碱是否可能对 COVID-19 的临床病程产生积极影响。(临床试验标识符:NCT04326790)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2605/7194546/5005e54773a8/fx1_lrg.jpg

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