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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550403
• Other study ID #: 27557
• Status: Completed
• Start date: July 30, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Diabetes Mellitus

Locations

Country	Name	City	State
Italy	Endocrinology and metabolic diseases Unit	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1. Review. — View Citation

Drucker DJ. Coronavirus Infections and Type 2 Diabetes-Shared Pathways with Therapeutic Implications. Endocr Rev. 2020 Jun 1;41(3). pii: bnaa011. doi: 10.1210/endrev/bnaa011. Review. — View Citation

Memish ZA, Perlman S, Van Kerkhove MD, Zumla A. Middle East respiratory syndrome. Lancet. 2020 Mar 28;395(10229):1063-1077. doi: 10.1016/S0140-6736(19)33221-0. Epub 2020 Mar 4. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients	to assess risk of intensive care unit admission and/or death among COVID-19 inpatients	february 23 to march 31, 2020
Secondary	prevalence of death among COVID-19 inpatients with and without diabetes	to compare risk of death among inpatients in presence or absence of diabetes	february 23 to march 31, 2020
Secondary	prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes	to compare intensive care unit admission among inpatients in presence or absence of diabetes	february 23 to march 31, 2020
Secondary	demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization	to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization	february 23 to march 31, 2020
Secondary	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	to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization	february 23 to march 31, 2020
Secondary	pharmacological therapies and death and/or intensive care unit admission during hospitalization	to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization	february 23 to march 31, 2020
Secondary	number of days of hospitalization in patients with and without diabetes	to compare total length of hospitalization in patients with or without diabetes	february 23 to march 31, 2020