A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,900
- 试验地点
- 53
- 主要终点
- Randomization WHO- Mortality
研究概览
简要总结
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.
详细描述
Subjects will be randomized, across one, two, three or up to four separate randomizations, to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.
Randomization WHO: Imatinib vs Infliximab vs Artesunate vs Standard of care
Randomization Dex: Dexamethasone vs Standard of care
Randomization LSALT: LSALT Peptide vs Standard of care
Hospitalized subjects will require blood sampling for screening and on days 1 and 5.
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
盲法说明
Endpoint assessment
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
- •Each participant must meet all of the following inclusion criteria to participate in this study:
- •≥ 18 years of age
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen, within 14 days prior to randomization.
- •Hospitalized at a participating centre
- •Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection
- •First admission for acute COVID19
- •In addition, there will be the below intervention-specific inclusion:
- •Randomization WHO will have no other specific inclusion criteria.
- •Randomization LSALT will have no other specific inclusion criteria.
- •Randomization Dex will have the following specific inclusion criteria
- •On 10 days of steroid course and
- •Receiving any supplemental oxygen for 10 days
排除标准
- •All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- •Anticipated transfer to another hospital, within 72 hours, which is not a study site
- •Expected to not survive beyond 24 hours
- •Receiving one of the study drugs at time of enrolment
- •In addition, there will be the below intervention-specific exclusions:
- •Randomization WHO:
- •These will be drug-specific exclusions; patients will still be eligible for randomization in Randomization WHO to the other available study drugs (in randomization WHO or subsequent randomizations).
- •Artesunate:
- •Known hypersensitivity to artesunate
- •Pregnant or breastfeeding;
- •Known hypersensitivity to imatinib;
- •Liver transaminases (either ALT or AST) > 5x upper limit of normal
- •Infliximab:
- •Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV
- •Known or suspected active tuberculosis
- •Known hypersensitivity to infliximab
- •Randomization LSALT:
- •Known hypersensitivity or prior use of LSALT peptide.
- •Pregnant or breastfeeding
- •Randomization Dex:
- •Receiving glucocorticoids for a specific, non-COVID-19 indication
研究组 & 干预措施
Artesunate
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
干预措施: Artesunate (Drug)
Imatinib
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
干预措施: Imatinib (Drug)
Infliximab
Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care
干预措施: Infliximab (Drug)
Dexamethasone
Subjects will be randomized between Dexamethasone vs standard of care.
干预措施: Dexamethasone (Drug)
LSALT Peptide
Subjects will be randomized between LSALT vs standard of care.
干预措施: LSALT Peptide (Drug)
结局指标
主要结局
Randomization WHO- Mortality
时间窗: 28 days
All-cause mortality, assessed at hospital discharge.
Randomization LSALT- Respiratory support
时间窗: 28 days
Number of days respiratory support free days
Randomization Dex- Clinical Status
时间窗: 28 days
Position on the WHO Ordinal scale at 28 days post-randomization. Ordinal Scale Table: 0 Uninfected; 1-3 Ambulatory; 4-5 Hospitalized/ Mild disease; 6-9 Hospitalized/ Severe Disease; 10 Death
次要结局
- CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT(24 months)
- Mortality(12 months)
- Evaluation of the clinical effectiveness of study drugs(24 months)
- Need for invasive mechanical ventilation(24 months)