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

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ClinicalTrials.gov Identifier: NCT04550403
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Riccardo Bonadonna, 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.

Condition or disease
Diabetes Mellitus Covid19

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550403


Contacts
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Contact: Riccardo Bonadonna, MD, PhD 00390521033307 riccardo.bonadonna@unipr.it
Contact: Alessandra Dei Cas, MD, PhD 00390521033321 alessandra.deicas@unipr.it

Locations
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Italy
Endocrinology and metabolic diseases Unit Recruiting
Parma, Italy, 43126
Contact: Riccardo Bonadonna, MD, PhD    00390521033307    riccardo.bonadonna@unipr.it   
Contact: Raffaella Aldigeri, MSc    00390521033306    raffaella.aldigeri@unipr.it   
Sub-Investigator: Tiziana Meschi, MD         
Sub-Investigator: Alessandra Dei Cas, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
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Principal Investigator: Riccardo Bonadonna, MD, PhD Azienda Ospedaliero-Universitaria di Parma
Publications:
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Responsible Party: Riccardo Bonadonna, Head of Endocrinology and metabolic diseases unit, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT04550403    
Other Study ID Numbers: 27557
First Posted: September 15, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Bonadonna, Azienda Ospedaliero-Universitaria di Parma:
diabetes
Covid-19
inhospital mortality
intensive care unit
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases