Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04550403|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
|Condition or disease|
|Diabetes Mellitus Covid19|
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|
|Estimated Enrollment :||700 participants|
|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|
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
|Contact: Riccardo Bonadonna, MD, PhDemail@example.com|
|Contact: Alessandra Dei Cas, MD, PhDfirstname.lastname@example.org|
|Endocrinology and metabolic diseases Unit||Recruiting|
|Parma, Italy, 43126|
|Contact: Riccardo Bonadonna, MD, PhD 00390521033307 email@example.com|
|Contact: Raffaella Aldigeri, MSc 00390521033306 firstname.lastname@example.org|
|Sub-Investigator: Tiziana Meschi, MD|
|Sub-Investigator: Alessandra Dei Cas, MD, PhD|
|Principal Investigator:||Riccardo Bonadonna, MD, PhD||Azienda Ospedaliero-Universitaria di Parma|