Comparison of the risk of serious adverse outcomes and clinical, laboratory and radiological characteristics in stable patients hospitalized with COVID 19 divided by co morbidity status
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Shifted to ICU
研究概览
简要总结
Background: The world is in themidst of the COVID19 pandemic. There is limited data available describingclinical, laboratory and radiological features and risk of serious adverseoutcomes in COVID19 patients in India. Furthermore, there is limited data onthe differences in presentation and outcomes of patients with COVID 19infection in patients with and without comorbidities.
We aim tocarry out this study with the following objectives:
Primary objectives: Predicting riskof serious adverse outcomes in mild/moderate patients hospitalized forCOVID 19 infection divided by comorbidity status.
Secondaryobjectives: Comparisonof clinical, laboratory, radiological data and outcomes in stable patients withand without comorbidities.
Rationalefor the study: COVID19 being a novel coronavirus disease there is limited data available in Indiaon disease presentation and risks of serious adverse outcomes in patients withand without comorbidities. Recently published research paper from China issuggestive of significant difference in outcomes of these two groups with COVID19 infection. So, by this study we would like to compare the two groups in ourIndian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients testing positive for SARSCoV2 by rRTpcr on a nasopharyngeal or oro pharyngeal swab Hemodynamically stable patients getting admitted to ward Able and willing to provide informed consent.
排除标准
- •Patients who meet any of the following criteria: 1.Critically ill patients defined as those a.Requiring ICU admission b.Requiring mech ventilation c.Radiographic imaging with severe bilateral ground glass opacities or consol-idation d.ARDS with PaO2/FiO2 300mm Hg or less e.Septic Shock requiring vasopressors f.Altered consciousness g.Multi organ failure as evidenced by CrCL <30 ml/min or receiving HD, CVVH or ALT > 5x upper limit of normal
- •Patients not giving informed consent.
结局指标
主要结局
Shifted to ICU
时间窗: Baseline
Death
时间窗: Baseline
Invasive mechanical ventilation
时间窗: Baseline
次要结局
- 1.Demographics: Age/Sex/If Healthcare worker/Flu vaccination/Smoking habits(2. Symptoms: Fever/Chills/Cough/Sputum/Hemoptysis/breath shortness/GI symptoms/Skin rash/)