COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL - COLCORONA

Montreal Heart Institute Coordinating Centre0 个研究点目标入组 6,000 人开始时间: 2020年10月16日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•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, dyspnoea 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;
•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

•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. Women of child bearing potential;
•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.

发起方

Montreal Heart Institute Coordinating Centre