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临床试验/NCT04367168
NCT04367168终止2 期

Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2020年5月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
116
试验地点
1
主要终点
Progression to severe disease

研究概览

简要总结

The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.

详细描述

This a placebo-controlled double-blind clinical trial to test the efficacy and security of colchicine 1.5 mg at day one followed by 0.5 mg BID to complete 10 days of treatment. The researchers will recruit patients 18-70 years of age who are hospitalized because of the diagnosis of mild or severe COVID-19. Patients will be randomized to receive one of the treatment arms, colchicine or placebo. The aim of the study is to evaluate if colchicine may be able to improve the outcomes in patients with mild and severe COVID-19. Patients will be followed-up during the entire hospitalization time and during convalescence. The importance of this intervention is highlighted because currently, there is not an effective treatment for the virus, nor for the prevention of the cytokine storm or the disseminated intravascular coagulation. Therefore, an early intervention to prevent the development of these complications would be valuable to prevent the morbi-morbidity secondary to severe and critical COVID-19

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age
  • Diagnosed with COVID-19 with mild or severe disease
  • Who must receive in-hospital care at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Who are able to take pills PO

排除标准

  • Concomitant participation in another clinical trial.
  • Hypersensitivity to colchicine
  • Pregnancy and lactation
  • Over 70 years
  • Kidney failure with creatinine clearance <30 mL / min.
  • Known liver failure
  • Concomitant medication that has interactions with colchicine and that due to its indication cannot be suspended or substituted

研究组 & 干预措施

Colchicine

Active Comparator

Colchicine PO

干预措施: Colchicine (Drug)

Placebo

Placebo Comparator

Placebo PO

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

Progression to severe disease

时间窗: Up to 10 days

At least one of the following: respiratory failure, respiratory rate \> 30 rpm, oxygen saturation \< 92%, PaO2/FiO2 \< 300 mmHg

Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels

时间窗: Up to 24 days

Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Sponsor

研究点 (1)

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