EUCTR2020-001258-23-IT进行中（未招募）1 期
COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA - ColCOVID19
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
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
- •-Patients aged 18 years or above
- •-Belonging to the low- to intermediate-risk strata according to the criteria of the Emilia-Romagna Region, Italy (PG/2020/0240975 del 21 marzo 2020 Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19”, Scenario 2 and 3A, in a scale of increased levels of severity) and to the SIMIT guidelines (http://www.simit.org/IT/formazione/linee-guida.xhtml)), that is patients in stable medical conditions (MEWS<3, see Table below) with the following characteristics:
- •-Pauci-symptomatic with positive nasopharyngeal swab for COVID-19 + age =70 years and/or clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) + even minimal CT scan findings (>5% of lung parenchima) suggestive of viral pneumonia (ground-glass opacities and/or patchy consolidation, and/or interstitial changes with a peripheral distribution)
- •- Symptomatic (temperature =38°C and/or intensive cough and/or shortness of breath), + CT imaging showing typical findings of viral pneumonia (ground-glass opacities, multifocal patchy consolidation, and/or interstitial changes with a peripheral distribution) and positive or pending pharyngo-nasal swab for COVID-19.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Unstable clinical conditions (MEWS=3)
- •- Respiratory rate > 30 rpm, PaO2/FiO2 < 200mmHg
- •- Pregnant or breast feeding
- •- Hepatic failure Child-Pugh C
- •- Enrollment in other pharmacological studies
- •Treatment with
- •- Chronic treatment with colchicine
- •- Ongoing treatment with antiviral drugs that include ritonavir or cobicistat (Previous treatment with antiviral drugs that include ritonavir or cobicistat is NOT an exclusion criteria)
- •- Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.
研究者
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