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NCT Number: NCT04550403

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

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.

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Key information

Conditions

Diabetes Mellitus COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology and metabolic diseases Unit

Parma, 43126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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