Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) (COVITOZ-01)
2021年8月24日 更新者：Jose A Perez Molina、Hospital Universitario Ramon y Cajal
Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
研究概览
地位
终止
条件
详细说明
National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.
The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.
78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.
研究类型
介入性
注册 (实际的)
26
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Madrid、西班牙、28034
- Hospital Universitario Ramón y Cajal
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
- The patient is hospitalized or meets hospital admission criteria.
- The patient is not expected to enter the ICU or die in the next 24 hours.
Exclusion Criteria:
- Participants in another simultaneous clinical trial.
- Use of other immunomodulators.
- Coinfection with the hepatitis B virus (detectable AgSup-HBV).
- Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
- Presence of laboratory abnormalities of grade ≥ 4.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TCZ 8 mg / kg one dose
TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
|
Tocilizumab 20 MG/ML Intravenous (one dose)
|
|
实验性的：TCZ 8 mg / kg in two
TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
|
Tocilizumab 20 MG/ML Intravenous ( two doses)
其他名称：
|
|
无干预：standard care treatment
Usual / standard care treatment
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
大体时间：Day1 and Day3.
|
Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
|
Day1 and Day3.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression of pneumonia
大体时间：Day3, Day7 and Day28
|
Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28
|
Day3, Day7 and Day28
|
|
PaO2/FiO2
大体时间：Day3, Day7 and Day28
|
Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.
|
Day3, Day7 and Day28
|
|
cause mortality to 28 days after started treatment
大体时间：Day3, Day7 and Day28
|
cause mortality to 28 days after started treatment
|
Day3, Day7 and Day28
|
|
Length of hospital stay
大体时间：Day3, Day7 and Day28
|
Length of hospital stay
|
Day3, Day7 and Day28
|
|
patients requiring Intensive Care Unit admission
大体时间：Day3, Day7 and Day28
|
Percentage of patients requiring Intensive Care Unit admission
|
Day3, Day7 and Day28
|
|
evolution of inflammatory parameters IL12
大体时间：Day0, Day3 and Day7
|
IL-12 levels at Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma
大体时间：Day0, Day3 and Day7
|
IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters Procalcitonin (PCT),
大体时间：Day0, Day3 and Day7
|
Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters C-reactive protein (PCR),
大体时间：Day0, Day3 and Day7
|
C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters D-dimer
大体时间：Day0, Day3 and Day7
|
D-dimer levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
evolution of inflammatory parameters and ferritin
大体时间：Day0, Day3 and Day7
|
ferritin levels on days Day0, Day1, Day3 and Day 7
|
Day0, Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmin
大体时间：Day0, Day1 Day3 and Day7
|
Cmin,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmax
大体时间：days Day0, Day1 Day3 and Day7
|
Cmax,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Cmedia
大体时间：days Day0, Day1 Day3 and Day7
|
Cmedia,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab Tmax
大体时间：days Day0, Day1 Day3 and Day7
|
Tmax,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
pharmacokinetics of tocilizumab AUC
大体时间：days Day0, Day1 Day3 and Day7
|
AUC,on Day0, Day1, Day3 and Day7.
On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.
|
days Day0, Day1 Day3 and Day7
|
|
Adverse event
大体时间：days Day0, Day3, Day7 and Day28
|
Serious and non-serious adverse events.
|
days Day0, Day3, Day7 and Day28
|
|
Adverse event to cause the treatment interruption.
大体时间：days Day0, Day3, Day7 and Day28
|
Adverse events to cause the treatment interruption.
|
days Day0, Day3, Day7 and Day28
|
|
Adverse event Abnormalities in laboratory
大体时间：days Day0, Day3, Day7 and Day28
|
Abnormalities in laboratory findings unrelated to COVID-19 disease.
|
days Day0, Day3, Day7 and Day28
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年5月4日
初级完成 (实际的)
2020年11月4日
研究完成 (实际的)
2021年2月10日
研究注册日期
首次提交
2020年6月11日
首先提交符合 QC 标准的
2020年6月16日
首次发布 (实际的)
2020年6月17日
研究记录更新
最后更新发布 (实际的)
2021年8月30日
上次提交的符合 QC 标准的更新
2021年8月24日
最后验证
2021年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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