Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Rate of entering the critical stage
研究概览
简要总结
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.
详细描述
This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.
One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent for participation in the study
- •Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- •Hospitalized due to clinical/instrumental diagnosis of pneumonia
- •Oxygen saturation at rest in ambient air ≤94%
- •PaO2/FiO2 ratio of 350 to 200
排除标准
- •Known hypersensitivity to colchicine or its excipients
- •Severe diarrhea
- •Patients who cannot take oral therapy
- •Pregnant and lactating patients
- •Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)
- •Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
- •Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
- •Neutrophils <1.000 / mmc
- •Platelets <50.000 / mmc
- •Bowel diverticulitis or perforation
- •Patients already in ICU or requiring mechanical ventilation
- •Patients receiving Tocilizumab
- •Patients already enrolled in other clinical trials
研究组 & 干预措施
Colchicine plus current care
Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator.
干预措施: Colchicine 1 MG Oral Tablet (Drug)
结局指标
主要结局
Rate of entering the critical stage
时间窗: [1 month]
Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Patients combined with other organ failure need ICU monitoring and treatment 3. Death
次要结局
- Rate of disease remission([up to 30 days])
- Trend of White blood cell count([up to 30 days])
- Rate of biochemical criterion (CK, ALT, ferritin) recovery([up to 30 days])
- Change of the "Sequential Organ failure Assessment" (SOFA)([up to 30 days])
研究者
Prof Roberto Gerli
Principal Investigator
University Of Perugia