Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 4,506
- 试验地点
- 32
- 主要终点
- Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
研究概览
简要总结
This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.
详细描述
The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population.
Approximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
Safety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, at least 40 years of age, capable and willing to provide informed consent;
- •Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;
- •Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
- •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;
- •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;
- •Patient must be able and willing to comply with the requirements of this study protocol.
排除标准
- •Patient currently hospitalized or under immediate consideration for hospitalization;
- •Patient currently in shock or with hemodynamic instability;
- •Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
- •Patient with pre-existent progressive neuromuscular disease;
- •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;
- •Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
- •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;
- •Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);
- •Patient with a history of an allergic reaction or significant sensitivity to colchicine;
- •Patient undergoing chemotherapy for cancer;
- •Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
Colchicine
Patients will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
干预措施: Colchicine (Drug)
Placebo
Patients will receive a placebo per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
时间窗: 30 days post randomization
The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.
次要结局
- Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.(30 days post randomization)
- Number of Deaths in the 30 Days Following Randomization.(30 days post randomization)
- Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.(30 days post randomization)