Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical response after administration
研究概览
简要总结
The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
详细描述
This is intervention single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. Patient's privacy and obey will be protected with the Helsinki Declaration.
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
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of all ages, males and non-pregnant females who will be diagnosed COVID-19 positive by RT-PCR.
- •Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- •Patient >55 years of age Or Age <55 with comorbid condition who will be unable to maintain O2 sat > 93% with 5-7 liter of oxygen.
- •Or Patient < 55 with no comorbid conditions, who will be unable to maintain O2 sat > 93% with 7-10 liter of oxygen.
- •Respiratory rate > 30-35/ min and >50% of radiological involvement of lung with typical lesions.
- •Along with > 50% deranged ≥ 2 biochemical markers CRP > 50 mg/l, LDH > 1000U/L, D.Dimer > 1mg/l or 1000 ng/ml, Serum Ferritin > 1000 ng/ml or mcg/l will be included in clinical trial.
排除标准
- •Patient who will not require supplemental oxygen during hospital stay.
- •Patients on Invasive mechanical ventilation (IMV).
- •Patients with respiratory rate < 30/mins and whose laboratory findings will not be deranged > 50%.
- •Patients with improving radiological findings will be excluded.
- •Patients suffering from Active TB
- •Herpes zoster
- •Multiple sclerosis,
- •Allergic to tocilizumab
- •Presences of chronic renal failure > 4 stage, GFR < 30ml/min/1.73m
- •ALT/AST > 5 times than normal values.
- •Presences of neutropenia < 500/mm
- •Platelets count less than 50 ×103 /µl.
- •Complicated diverticulitis/ intestinal perforation.
- •Immune-suppressive anti- rejection therapy.
- •Pregnant women.
- •Previous MI/ IHD, IV heart failure.
- •Psychiatric patients.
研究组 & 干预措施
Group intervene with Tocilizumab
Review effect of Tocilizumab as clinical trial among hospitalized patients with COVID-19 infection.
Participants with severe disease will receive an intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg) tocilizumab. Specifically, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory biomarkers.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Clinical response after administration
时间窗: 10 days
Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.
次要结局
- Clinical outcome of the treatment(15 days)
- Clinical response to treatment(15 days)
- Duration of hospitalization(15 days)
- Supplemental Oxygen Requirement from Baseline(15 days)
研究者
Dr. M.Irfan Malik
Associate Professor of Pulmonology / Focal Person COVID-19
Lahore General Hospital