Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
- 试验地点
- 27
- 主要终点
- Lethality rate two weeks after registration
研究概览
简要总结
This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.
详细描述
Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30 days) lethality rates are the co-primary endpoints.
The parallel cohort includes patients who are treated with tocilizumab and cannot enter the phase 2 study because:
- emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or
- they had been intubated more than 24 hours before registration or
- the phase 2 study has been closed due to reached sample size.
This means that, after closure of the phase 2 enrolment, patients who might be eligible for the phase 2 study will be included in the observational cohort study.
The same information planned for the phase 2 cohort is required also for the parallel cohort study whose sample size is not defined a priori, and that will close at the end of the overall project. All the patients enrolled are treated with tocilizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age limit
- •Informed consent for participation in the study (consent can be oral if a written consent cannot be expressed. If the subject is incapable of giving an informed consent and an authorized representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life-saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon the conditions of the patient will allow it)
- •Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- •Hospitalized due to clinical/instrumental diagnosis of pneumonia
- •Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated)
- •Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort
排除标准
- •Known hypersensitivity to tocilizumab or its excipients
- •Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician
- •ALT / AST> 5 times the upper limit of the normality
- •Neutrophils <500 / mmc
- •Platelets <50.000 / mmc
- •Bowel diverticulitis or perforation
研究组 & 干预措施
tocilizumab treatment
All the patients enrolled are treated with tocilizumab.
干预措施: Tocilizumab Injection (Drug)
结局指标
主要结局
Lethality rate two weeks after registration
时间窗: up to 15 days
2-week lethality is defined as the ratio of the number of subjects dead within 14 days from study start out of phase 2 patients with baseline information.
Lethality rate one month after registration
时间窗: up to 1 month
1-month lethality is defined as the ratio of the number of subjects dead within 30 days from study start out of phase 2 patients with baseline information.
次要结局
- Lymphocyte count(baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month)
- PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)(baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month)
- Remission of respiratory symptoms(up to 1 month)
- Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0(during treatment and up to 30 days after the last treatment dose)
- Interleukin-6 level(baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month)
- CRP (C-reactive protein) level(baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month)
- Change of the SOFA (Sequential Organ Failure Assessment)(baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month)
- Radiological response(at baseline (optional), after seven days and if clinically indicated (up to 1 month))
- Duration of hospitalization(from baseline up to patient's discharge (up to 1 month))