EUCTR2020-001475-33-IT进行中（未招募）1 期
Treatment with COLchicine of patients affected by COVID-19: a Pilot Study - Colchicine in COVID-19: a Pilot study
DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA0 个研究点目标入组 308 人开始时间: 2020年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 308
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
- •1.Any gender
- •2.>=18 years old
- •3.Informed consent for participation in the study
- •4.Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- •5.Hospitalized due to clinical/instrumental diagnosis of pneumonia
- •6.Oxygen saturation at rest in ambient air =94%
- •7.PaO2/FiO2 ratio of 350 to 200
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 215
排除标准
- •1.Known hypersensitivity to colchicine or its excipients
- •2.Severe diarrhea
- •3.Patients who cannot take oral therapy
- •4.Pregnant and lactating patients
- •5.Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL
- •6.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.
- •7.Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
- •8.Neutrophils <1.000 / mmc
- •9.Platelets <50.000 / mmc
- •10.Bowel diverticulitis or perforation
- •11.Patients already in ICU or requiring mechanical ventilation
- •12.Patients receiving Tocilizumab
- •13.Patients already enrolled in other clinical trials
研究者
相似试验
招募中
3 期
Colchicine effects in patients with sepsisSepsis.Symptoms and signs specifically associated with systemic inflammation and infectionIRCT20231017059748N1Tabriz University of Medical Sciences44
招募中
3 期
Effect of Colchicine in patient presenting with non ST-elevation myocardial infarctioIRCT20190601043780N1Mashhad University of Medical Sciences140
尚未招募
Unknown
Clinical outcomes of colchicine therapy following percutaneous coronary intervention in patient s with acute coronary syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) prospective multicenter observational studyDiseases of the circulatory systemKCT0009444Bundang CHA General Hospital490
招募中
3 期
Evaluation of colchicine in treatment of coronavirusPulmonary infection of COVD19.Coronavirus infection, unspecifiedB34.2IRCT20200418047126N1Ardabil University of Medical Sciences100
招募中
2 期
Effect of Colchicine on aphthous ulceration.Aphthous.Recurrent oral aphthaeK12.0IRCT20160920029889N4Mazandaran University of Medical Sciences10