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

February 16, 2022 updated by: Riccardo Bonadonna, Azienda Ospedaliero-Universitaria di Parma
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43126
        • Endocrinology and metabolic diseases Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with and without diabetes, hospitalized for COVID-19 between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
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
Time Frame: february 23 to march 31, 2020
to compare total length of hospitalization in patients with or without diabetes
february 23 to march 31, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Investigators

  • Principal Investigator: Riccardo Bonadonna, MD, PhD, Azienda Ospedaliero-Universitaria di Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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