Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 276
- 试验地点
- 7
- 主要终点
- Need for mechanical ventilation in the Intensive Care Unit
研究概览
简要总结
COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.
Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.
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
- •Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
- •Understand and agree to abide by the study procedures.
- •Adult #18 years of age at the time of inclusion in the study.
- •Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
- •Severity 3-4 according to the WHO 7-point ordinal scale.
排除标准
- •ALT / AST> 5 times the normal limit
- •Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
- •Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
- •Advanced dementia.
- •Pregnancy or breastfeeding.
- •Anticipation of transfer to another center in the 12 hours at the beginning of the study.
- •Allergy to study medication.
- •Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-
- •Streptococcus pneumoniae antigenuria positive before study start.
- •Neutropenia <500 / mm
- •Thrombocytopenia <100,000 / mm
- •History of diverticulosis.
- •Ongoing skin infection (eg, pyodermitis).
- •Transplanted patient under immunosuppressive treatment.
- •Previous evidence of latent untreated tuberculosis.
研究组 & 干预措施
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
干预措施: Tocilizumab (Drug)
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
干预措施: Hydroxychloroquine (Drug)
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
干预措施: Azithromycin (Drug)
Control
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
干预措施: Hydroxychloroquine (Drug)
Control
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Need for mechanical ventilation in the Intensive Care Unit
时间窗: Through hospitalization, an average of 2 weeks
In-hospital mortality
时间窗: Through hospitalization, an average of 2 weeks
次要结局
未报告次要终点