EUCTR2020-001689-12-GR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19日最近更新:
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 within the last 24 hours
- •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, bicytopenia,
- •pancytopenia, or the combination of high neutrophil count and low lymphocyte count.
- •5. Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after
- •study completion.
- •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 enrollment, with a cut-off of < 30 mL/m in/1.73m2.
- •6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease
- •7. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication.
- •8. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment.
- •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.
研究者
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