EUCTR2020-001689-12-GB进行中（未招募）1 期
COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL - COLCORONA
Montreal Health Innovations Coordinating Centre0 个研究点目标入组 6,000 人开始时间: 2020年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of these criteria must be met:
- •1. Males and females, at least 40 years of age, capable and willing to provide informed consent;
- •2. Patient must have received a diagnosis of COVID-19 infection and a positive SARS-CoV-2 with a valid COVID-19 test
- •3. Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
- •4. Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI = 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure =150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of =38.4°C within the last 48 hours, dyspnea at the time of presentation or the combination of high neutrophil count and low lymphocyte count;
- •5.Only female patients who are not of child-bearing potential are eligible for inclusion. Women must either be postmenopausal for at least 1 year or surgically sterile (hysterectomy or bilateral salpingectomy);
- •6. Patient must be able and willing to comply with the requirements of this study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •None of these exclusion criteria should be met:
- •1. Patient currently hospitalized or under immediate consideration for hospitalization;
- •2. Patient currently in shock or with haemodynamic instability;
- •3. Patient with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or patient with chronic diarrhoea;
- •4. Patient with pre-existenting progressive neuromuscular disease;
- •5. Estimated glomerular filtration rate (eGFR) using the MDRD equation for all subjects being considered for enrolment with a cut off of <60ml/min/1.73m2 (Result must be obtained in the 60 days prior to the screening date)
- •6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
- •7. Women of child bearing potential;
- •8. Patient who has ever taken colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout).
- •9. Patient with a history of an allergic reaction or significant sensitivity to colchicine;
- •10. Patient undergoing chemotherapy for cancer;
- •11. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •Additional in UK:
- •12. Patient taking P-Glycoprotein inhibitors and strong CYP3A4 inhibitors at screening or 14 days previously will not be eligible for inclusion in the trial:
- •P-Glycoprotein inhibitors such as ciclosporin, ranolazine, verapamil and quinidine
- •Strong cytochrome P450 (CYP3A4) inhibitors including atazanavir, boceprevir, erythromycin, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, also darunavir, lopinavir and tipranavir when used in combination with ritonavir.
- •Please note the above lists are not exhaustive. See prescribing information for the UK for further information.
- •13.Patient with bicytopenia or pancytopenia
研究者
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