Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
研究概览
简要总结
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •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.
排除标准
- •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.
研究组 & 干预措施
TCZ 8 mg / kg one dose
TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
干预措施: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (Drug)
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
干预措施: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) (Drug)
结局指标
主要结局
Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.
时间窗: 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.
次要结局
- patients requiring Intensive Care Unit admission(Day3, Day7 and Day28)
- evolution of inflammatory parameters Procalcitonin (PCT),(Day0, Day3 and Day7)
- evolution of inflammatory parameters and ferritin(Day0, Day3 and Day7)
- Length of hospital stay(Day3, Day7 and Day28)
- Progression of pneumonia(Day3, Day7 and Day28)
- evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma(Day0, Day3 and Day7)
- evolution of inflammatory parameters C-reactive protein (PCR),(Day0, Day3 and Day7)
- pharmacokinetics of tocilizumab Cmedia(days Day0, Day1 Day3 and Day7)
- PaO2/FiO2(Day3, Day7 and Day28)
- pharmacokinetics of tocilizumab Tmax(days Day0, Day1 Day3 and Day7)
- pharmacokinetics of tocilizumab AUC(days Day0, Day1 Day3 and Day7)
- Adverse event Abnormalities in laboratory(days Day0, Day3, Day7 and Day28)
- cause mortality to 28 days after started treatment(Day3, Day7 and Day28)
- Adverse event(days Day0, Day3, Day7 and Day28)
- Adverse event to cause the treatment interruption.(days Day0, Day3, Day7 and Day28)
- evolution of inflammatory parameters IL12(Day0, Day3 and Day7)
- evolution of inflammatory parameters D-dimer(Day0, Day3 and Day7)
- pharmacokinetics of tocilizumab Cmin(Day0, Day1 Day3 and Day7)
- pharmacokinetics of tocilizumab Cmax(days Day0, Day1 Day3 and Day7)
研究者
Jose A Perez Molina
Sponsor
Hospital Universitario Ramon y Cajal