"COVID-19 and Diabetes Outcomes" (CORONADO)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Diabetes; Coronavirus

Treatments: Other: no interventional study

Study type: Observational

Funder types: Other

Identifiers

NCT04324736

RC20_0148

Details and patient eligibility

About

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death.

Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies.

This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

Enrollment: 5,309 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients admitted in a hospital center since 10th march 2020
• Patients with COVID19 with biological proof (specific PCR) or with clinical and radiological diagnosis.
• Patient with diabetes known before the admission
• New onset diabetes discovered at admission (HbA1c value strictly greater than 6.5%)

exclusion criteria

• subjects opposed to the use of their data
• minors, adults under guardianship, protected persons
• subject having already been included in the CORONADO study (subject readmitted after discharge following the initial stay). Only the data of the first stay will be maintained.

Trial design

5,309 participants in 2 patient groups

Patients with diabetes

Treatment:

Other: no interventional study

Patients without diabetes

Treatment:

Other: no interventional study