NCT04591704

Brief Summary

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

March 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

October 16, 2020

Last Update Submit

May 1, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Duration of Hospitalisation

    The time between admission to hospital and discharge

    1 year

  • The need for ICU

    The admission of hospitalized patients to the intensive care unit.

    1 year

  • Mortality

    Mortality rates of patients

    1 year

  • Lung involvement

    The presence of lung involvement on thorax CT

    1 year

Study Arms (2)

Diabetic groups

COVID-19 patients with diabetes mellitus

Other: hospitalisation, necessity of ICU, mortality rate, lung involvement

Control groups

COVID-19 patients without diabetes mellitus

Other: hospitalisation, necessity of ICU, mortality rate, lung involvement

Interventions

hospitalisation, necessity of ICU, mortality rate, lung involvement

Control groupsDiabetic groups

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study

You may qualify if:

  • Patients hospitalized for COVID-19

You may not qualify if:

  • Patients with known malignancy
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak University Training and Research Hospital

Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19Diabetes Mellitus

Interventions

HospitalizationMortality

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Cevdet Duran

    Uşak Üniversitesi Tıp fak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 19, 2020

Study Start

March 20, 2020

Primary Completion

October 15, 2020

Study Completion

July 1, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations