Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 1
- 主要终点
- prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
研究概览
简要总结
Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.
详细描述
The epidemic of coronavirus disease-2019 (COVID-19), a disease caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus, rapidly spread worldwide and was declared a pandemic by the World Health Organization on 11 March 2020.
It is well known that people with diabetes have increased infection risk, especially for influenza and pneumonia. Moreover, diabetes was previously reported as a major risk factor for mortality in people infected with the H1N1 pandemic influenza and, more recently, with the Middle East respiratory syndrome-related coronavirus (MERS-CoV) . Epidemiological studies have quickly and consistently pointed out diabetes as one of the major comorbidities associated with COVID-19 and affecting its severity.
The prevalence of diabetes in patients with COVID-19 was first reported to range from 5% to 20%. Furthermore, the COVID-19-Associated Hospitalisation Surveillance Network (COVID-NET) reported a diabetes prevalence of 28.3% in hospitalised patients in the USA.
More importantly, all studies published so far have reported a two- to threefold higher prevalence of diabetes in patients in ICUs compared with those with less severe disease and an increased mortality in people with diabetes. A recent meta-analysis further demonstrated that diabetes was associated with a more than doubled risk for ICU admission and a more than tripled risk for death.
However, precise data regarding diabetes characteristics in hospitalised people with COVID-19 are still lacking. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This study aims to identify the clinical and biological features and potential interactions of diabetic therapies associated with disease severity and mortality risk in people hospitalised for COVID-19. Hospital medical records of inpatients, hospitalized between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy will be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission with COVID-19 to the Internal Medicine Unit dedicated to COVID-19 (Macrounit 1), academic hospital in Parma (Italy) between February 23 to March 31 2020.
排除标准
- •during hospitalization inter or intra-hospital transfer of inpatients
结局指标
主要结局
prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
时间窗: february 23 to march 31, 2020
to assess risk of intensive care unit admission and/or death among COVID-19 inpatients
次要结局
- prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes(february 23 to march 31, 2020)
- demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization(february 23 to march 31, 2020)
- number of days of hospitalization in patients with and without diabetes(february 23 to march 31, 2020)
- prevalence of death among COVID-19 inpatients with and without diabetes(february 23 to march 31, 2020)
- laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization(february 23 to march 31, 2020)
- pharmacological therapies and death and/or intensive care unit admission during hospitalization(february 23 to march 31, 2020)
研究者
Riccardo Bonadonna
Head of Endocrinology and metabolic diseases unit
Azienda Ospedaliero-Universitaria di Parma