NCT04550403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

September 10, 2020

Last Update Submit

February 16, 2022

Conditions

Diabetes MellitusCovid19

Keywords

diabetesCovid-19inhospital mortalityintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • prevalence of death among COVID-19 inpatients with and without diabetes

    february 23 to march 31, 2020

  • prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes

    february 23 to march 31, 2020

  • demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization

    february 23 to march 31, 2020

  • 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

    february 23 to march 31, 2020

  • pharmacological therapies and death and/or intensive care unit admission during hospitalization

    february 23 to march 31, 2020

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • during hospitalization inter or intra-hospital transfer of inpatients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology and metabolic diseases Unit

Parma, 43126, Italy

Location

Related Publications (5)

  • 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.

    PMID: 32145185BACKGROUND

  • 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.

    PMID: 18948167BACKGROUND

  • 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.

    PMID: 19333547BACKGROUND

  • 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.

    PMID: 32294179BACKGROUND

  • 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.

    PMID: 32267833BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusCOVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Riccardo Bonadonna, MD, PhD

    Azienda Ospedaliero-Universitaria di Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Endocrinology and metabolic diseases unit

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 16, 2020

Study Start

July 30, 2020

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations

IT(1)