An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 126
- 试验地点
- 25
- 主要终点
- Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation
研究概览
简要总结
The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.
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
- •age > 18 years
- •Informed consent for participation in the study
- •Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection
- •Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or pulmonary ultrasound)
- •Presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg
- •Presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria:
- •At least one body temperature measurement >38° C in the past two days;
- •Serum CRP greater than or equal to 10 mg/dl;
- •CRP increase of at least twice the basal value
排除标准
- •Patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) <200 mm/Hg or
- •Patients in non-invasive ventilation or
- •Patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the Intensive Care Unit
- •Severe heart and kidney failure
- •Pregnant or breastfeeding patient
- •Patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture.
- •Known hypersensitivity to TCZ or its excipients
- •Patient being treated with immuno-depressors or anti-rejection drugs
- •Known active infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment
- •glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm
- •Neutrophils <500 /mmc
- •Platelets <50.000 /mmc
- •Diverticulitis or intestinal perforation
- •Suspicion of latent tuberculosis
研究组 & 干预措施
Experimental Arm
Tocilizumab within 8 hours from entering the study + standard of care; 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
干预措施: Tocilizumab (Drug)
Control Arm
Standard of care; In the event of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation
时间窗: two weeks from participants' allocation to study arm
Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation documented by the finding of a PaO2 / FiO2 ratio \<150mm / Hg confirmed by a second arterial blood gas (ABG) measurement within four hours
次要结局
- Death from any cause(Two weeks from participants' allocation to study arm)
- Tocilizumab toxicity(Two weeks from participants' allocation to study arm)
- Levels of interleukin-6 and C-reactive protein (CRP) and their correlation with the effectiveness of the treatment(Two weeks from participants' allocation to study arm)
- Evaluate the progress of the PaO2 / FiO2 ratio(Two weeks from participants' allocation to study arm)
- Evaluate the trend over time of the lymphocyte count(Two weeks from participants' allocation to study arm)