Clinical trial NCT04550403: Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
Official title: Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Covid19
Keywords: diabetes
Covid-19
inhospital mortality
intensive care unit
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 757
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
timeFrame: february 23 to march 31, 2020
Secondary outcomes:
measure: prevalence of death among COVID-19 inpatients with and without diabetes
timeFrame: february 23 to march 31, 2020
measure: prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes
timeFrame: february 23 to march 31, 2020
measure: demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization
timeFrame: february 23 to march 31, 2020
measure: 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
timeFrame: february 23 to march 31, 2020
measure: pharmacological therapies and death and/or intensive care unit admission during hospitalization
timeFrame: february 23 to march 31, 2020
measure: number of days of hospitalization in patients with and without diabetes
timeFrame: february 23 to march 31, 2020
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Endocrinology and metabolic diseases Unit
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Parma
name: Riccardo Bonadonna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
citation: Drucker DJ. Coronavirus Infections and Type 2 Diabetes-Shared Pathways with Therapeutic Implications. Endocr Rev. 2020 Jun 1;41(3):bnaa011. doi: 10.1210/endrev/bnaa011.
citation: Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.