CTRI/2021/05/033703进行中（未招募）3 期
A Phase-III, Multicenter, Prospective, Double Blind, Randomized, Parallel, Clinical Study Evaluating the Efficacy, Safety and Tolerability of Hetero-Tocilizumab in Cytokine Storm of Severe Coronavirus Disease (Covid-19) Pneumonia (TOCICOVID Study)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
- 试验地点
- 10
- 主要终点
- Cumulative proportion of patients requiring mechanical ventilation
研究概览
简要总结
This is a multicentric, prospective, double blind, randomized, parallel, clinical study to evaluate the efficacy, safety and tolerability of Hetero-Tocilizumab therapy in patients with cytokine storm of severe corona virus disease (COVID-19) pneumonia. This is a parallel study with enrolment in 3:1 ratio. Standard of care will be given in both arms as per the Clinical Management Protocol of ICMR, Ministry of Health and Family Welfare, Government of India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent.
- •Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
- •Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air.
- •Patients with elevated IL-6 (>40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP (>75mg/L) and ferritin 5X ULN.
排除标准
- •Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation.
- •Patients requiring intubation and mechanical ventilation
- •Patients with ALT/AST ≥ 5 x upper limit of normal (ULN)
- •Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm
- •Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months
- •Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer
- •Evidence of multiorgan failure
- •Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
- •Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.
结局指标
主要结局
Cumulative proportion of patients requiring mechanical ventilation
时间窗: Day 14
次要结局
- Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO)(Day 14 and 28)
- Time to 2-point decrease in ordinal scale (as recommended by WHO) from randomization.(Up to Day 28)
- Incidence and severity of TEAEs (clinical and laboratory) during the study(All Visits)
- Proportion of patients discontinued the study due to adverse events(All Visits)
- Mortality Rate during the study(Day 14 and 28)
研究者
研究点 (10)
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