Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Proportion of participants with Overall Survival at 14 days
研究概览
简要总结
randomized controlled trial comparing survival benefit of Tocilizumab therapy with dexamethasone in patients with severe COVID 19
详细描述
The current study takes place in the ICU of ESNA hospital, the first COVID-19 quarantine hospital in Egypt, located in Upper Egypt, Luxor governorate during the period from March 2020 to June 2020.
The diagnosis of COVID-19 was made with a positive RT-PCR assay performed on a nasal swab. We have collected data on patients' demographics, comorbidities, symptoms, oxygen support, the ratio of partial pressure of arterial oxygen over the fraction of inspired oxygen (PaO2/FiO2 ratio), laboratory values (complete blood count, CRP, D-Dimer, ferritin, AST, ALT), diagnostic workup, therapies, complications, and outcomes.
Patients were given conventional treatment for COVID-19, including, hydroxychloroquine with a loading dose of 400 mg twice daily followed by 200 mg per day twice daily for additional five days and azithromycin 500 mg per day for five days unless contraindicated. An electrocardiogram was obtained for each patient to check the corrected QT interval at baseline.
In addition to conventional treatment, patients were randomly assigned to either dexamethasone group or tocilizumab (TCZ) group according to random tables.
Eligibility for study included patients with significant deterioration in respiratory clinical status with respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500).Interleukin 6 levels were not part of the criteria because it did not necessarily result in an actionable time frame.
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
- Double (Participant, Outcomes Assessor)
盲法说明
single blind
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
- •respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500)
排除标准
- •Pediatric patients < 18 years old, patients with active bacterial or fungal infection and patients who were not requiring supplemental oxygen
研究组 & 干预措施
Tocilizumab
Tocilizumab
干预措施: Tocilizumab (Drug)
Dexamethasone
Dexamethasone therapy
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Proportion of participants with Overall Survival at 14 days
时间窗: 14 days
survival 14 days from admission date
次要结局
- Fio2/Pao2(2 days)
研究者
Alaa Rashad
Assistant professor
South Valley University
