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

Completed

• Conditions: Covid19; Diabetes Mellitus

• Registration Number: NCT04550403
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 757

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes	february 23 to march 31, 2020	to compare intensive care unit admission among inpatients in presence or absence of diabetes
demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization	february 23 to march 31, 2020	to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
number of days of hospitalization in patients with and without diabetes	february 23 to march 31, 2020	to compare total length of hospitalization in patients with or without diabetes
prevalence of death among COVID-19 inpatients with and without diabetes	february 23 to march 31, 2020	to compare risk of death among inpatients in presence or absence of diabetes
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	to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
pharmacological therapies and death and/or intensive care unit admission during hospitalization	february 23 to march 31, 2020	to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization

Trial Locations

Locations (1)

Endocrinology and metabolic diseases Unit; 🇮🇹 Parma, Italy