Comparative Study Evaluating Clinical Outcomes for Patients Treated With Tocilizumab for Sever COVID-19 Infection in Breast Cancer Patients Versus Non Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
To compare evaluating Clinical outcomes for patients treated with with or without breast cancer patients comorbidity for sever COVID-19 infection in breast cancer patients versus non cancer patients and evaluating Tocilizumab efficacy versus traditional therapy
详细描述
Cancer patients considered to be one of the least population that can be considered lucky during COVID 19 pandemic attributed that to long term treatment with chemotherapy, immunosuppression and multi comorbidities . Women with breast cancer are more likely to get covid-19 infection rather than other type cancers . the co-existing of two diseases breast cancer and Covid19 are very challengeable due to confusion and similarities found in clinical biomarkers to evaluate both diseases as ferritin, D dimers and C-reactive protein and all other immune response and cytokine storm syndrome especially including interleukin-6 (IL-6) . using chemotherapy or any other cytotoxic drugs may exacerbate the severity of COVID -19 infection as well as poor clinical outcomes and even death are expected . The anti-human IL-6R monoclonal antibody (Tocilizumab) was used first in China in patients with severe COVID-19 and patients improved in different clinical outcome . In cancer patients particularly the issue is debatable about the benefits of receiving Tocilizumab.
Clinical studies are going on such medication role in treatment of patients with severe covid 19 infection however, studies have not clearly addressed the role of Tocilizumab breast cancer patient compared to non-cancer patients. This study aims to measure different clinical outcomes after using Tocilizumab in sever covid 19 infection in breast cancer patients vs. non cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to ICU with or without breast cancer (non-metastatic) comorbidity
- •age 18-85 years' old
- •moderate to sever confirmed COVID 19 infection through PCR and CT
- •male or female
- •confirmed Covid-19 by PCR
- •Requiring ICU admission
- •WITH evidence of severe COVID-19 (at least 2 of the following):
- •Fever > 38C within 72 hours
- •Pulmonary infiltrate on chest X ray /ground glass opacity
- •Need for supplemental O2 to maintain saturation > 92%
- •AND at least 1 of the following:
- •Ferritin > 500 ng/ml
- •CRP > 50 mg/L
- •LDH >250 U/L
- •D-dimer > 1000 ng/mL
- •all patient assigned informed consent
排除标准
- •above 85 years' old
- •metatastic breast cancer
- •autoimmune disease patients
- •Unable to provide verbal informed consent
- •Subjects between the ages of 70 and 75 will be excluded if they have NYHA Class III/IV heart failure
- •Receipt of IV tocilizumab for the treatment of a non-COVID condition within 3 weeks of the first COVID symptom
- •History of hypersensitivity to tocilizumab
- •ANC <500, Platelets <50,000*
- •AST/ALT > 5X ULN
研究组 & 干预措施
Svere infected Covid-19 control
Arm one confirmed sever COVID 19 infection admitted to ICU including with or without breast cancer patients comorbidity receive traditional therapy
干预措施: traditional Covid -19 therapy (Drug)
sever infected Covid -19 pateints study
Arm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab
干预措施: Tocilizumab (Drug)
结局指标
主要结局
progression free survival (PFS)
时间窗: 3 months
measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab
time of improvement or worsening at least one point change in ordinal scale
时间窗: 28 days
Time to improvement will be assessed by changes on the clinical improvement or worsening as it measures illness severity over time ,by using Ordinal Scale for Clinical Improvement which score zero indicate no clinical or evidence virologic infection and high score 8 indicate death
Overall survival (OS) after treatment of Tocilizumab
时间窗: 28 days time fram
measure mortality rate
次要结局
- measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required(28 days time fram)
- Duration of mechanical ventilation(28 days)
- adverse effect(28 days)
- length of stay in Intensive care unit(28 days)
研究者
ALshaimaa Ibrahim Rabie
Assistant lecturer , pharm D, October 6 University
Beni-Suef University