Study on characteristics and prognosis of diabetes and non diabetes patients with COVID 19 among southern Indian population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,050
- 试验地点
- 4
- 主要终点
- To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection
研究概览
简要总结
Thefollowing data from a person tested positive for COVID 19 and hospitalized willbe collected. Patient’s anthropometry (height in cms, weight in kgs, and body mass index in kg/m2), blood pressure, symptoms of COVID-19 (fever,fatigue, cough, cephalalgia, dyspnoea, rhinitis, pharyngeal symptoms, ageusia,anosmia, digestive disorders), history ofsmoking, hypertension, dyslipidemia, microvascular (retinopathy, nephropathyand neuropathy), macrovascular (coronary artery disease, cerebrovasculardisease and peripheral vascular disease) complications and other comorbidconditions will be recorded. Fasting blood glucose, HbA1c, and any otherrelevant investigations if available and treatment for COVID-19 and other comorbid conditions will be recorded.
Detailsof patients developing new symptoms, shifted to ICU, intubated, or died duringthe course of treatment will be recorded. The appearance of any complication duringthe stay at the hospital will be recorded. The changes in the treatment patternduring the course of the disease will also be noted.
The registry will be fully anonymized and statisticians will have noaccess to patients’ personal identifiers. All “investigators†will have toregister before entering data in the registry. Data about clinical observationsfor the individual patient will be entered by clinicians or by authorizedresearch personnel of the care team in the registry.
Patients’ names, dates of birth, date of death,residential postal code, hospital number will be fully anonymized at the source. Inno circumstances, patients’ identifiable data be available to anyone outsidetheir own care teams or authorized local administration/research personnel. Patientdata will not at any stage be in identifiable form by the registrymanagers. The data to be collected from the patients are mentioned in the visitchart.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •>18 yrs male or female COVID-19 positive.
排除标准
- •COVID 19 Negative New-onset Diabetes with covid-19 infection.
结局指标
主要结局
To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection
时间窗: 14 days
次要结局
- Number of patients who were in ICU(14 days)
- Number of patients who had respiratory complication(14 days)
- •No. of patients who developed complications during the disease period (retinopathy, nephropathy, neuropathy, ischemic heart disease, cerebrovascular disease, peripheral artery disease, diabetic foot ulcer, hypertension, dyslipidemia)(14 days)
- Number of patients who had tracheal intubation(14 days)
- Number of death(14 days)
- Length of hospital stay(14 days)
- No. of patients recovered and discharged(14 days)
- Pattern of treatment for coexisting diabetes, hypertension, dyslipidemia and coronary artery disease(14 days)