Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes

Conditions
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Diabetes Mellitus, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: during hospitalization inter or intra-hospital transfer of inpatients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients | to assess risk of intensive care unit admission and/or death among COVID-19 inpatients | february 23 to march 31, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of death among COVID-19 inpatients with and without diabetes | to compare risk of death among inpatients in presence or absence of diabetes | february 23 to march 31, 2020 | 
| prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes | to compare intensive care unit admission among inpatients in presence or absence of 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 | to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization | 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 | to identify laboratory variables as predictors of severe prognosis (death 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 | to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization | february 23 to march 31, 2020 | 
| number of days of hospitalization in patients with and without diabetes | to compare total length of hospitalization in patients with or without diabetes | february 23 to march 31, 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, Covid-19, inhospital mortality, intensive care unit