Tocilizumab for Treatment of SARS Cov2 Pneumonia. Experience in a Private Health Center Facility in Buenos Aires City.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
We conducted a retrospective observational study of adult participants receiving only SOC (dexamethasone 8 mg or its equivalent plus oxygen, HNFO or eventual IMV) versus participants receiving SOC plus TCZ (8mg/kg as a single dose) as treatment for severe or critical SARS CoV2 pneumonia. The inclusion date will be the date of admission, and follow up will conclude at death or discharge (whichever occurs first) to describe clinical and laboratory characteristics and outcome of adult participants receiving only standard of care (SOC) versus participants receiving SOC plus TCZ as treatment for severe or critical SARS CoV2 pneumonia.
详细描述
Settings Emergency Department, General Ward and Intensive Care Unit (ICU) at Sanatorio Finochietto in Buenos Aires City, Argentina. Sanatorio Finochietto is a third level health care facility that provides health care services in prevalent clinical and surgical pathologies. It has the formerly mentioned units; as well as a Maternity Ward and complementary services (such as Laboratory, Radiology and Hemodynamics) and a total of 161 beds 30 of which are ICU beds.
Population Adult participants 18 years old and older receiving SOC plus TCZ versus only SOC as treatment for severe or critical SARS CoV2 pneumonia in Sanatorio Finochietto, between March 1st and August 31st 2021.
Participants in the control group couldn't receive TCZ because they were out of therapeutic window or had secondary infections suspicion.
Exposure variable is TCZ yes/no.
Inclusion Criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •18 years and older at admission.
- •Confirmed diagnosis of severe SARS CoV 2 infection.
- •category 6 and 7 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
排除标准
- •under 18 years of age no Confirmed diagnosis of SARS CoV 2 infection. category 1dnd 5 of World's Health Organization (WHO) COVID 19 ordinal scale on Clinical Improvement .
结局指标
主要结局
Death
时间窗: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
death during hospitalization
Secondary infections
时间窗: From the date of admission to the date of death from any cause or discharge from hospital, whichever occurs first
infection demonstrated with cultures of blood, urine, or respiratory specimens during hospitalization
WHO COVID 19 ordinal scale on Clinical Improvement and the 14 days
时间窗: 14 days
difference in the who ordinal scale between the date of worsening and the 14 days of the same, with 1 being the best value and 8 the worst (death)
次要结局
未报告次要终点
研究者
Nazareno Galvalisi
Doctor
Sanatorio Finochietto