"COVID-19 and Diabetes Outcomes"

Completed

• Conditions: Coronavirus; Diabetes
• Interventions: Other: no interventional study

• Registration Number: NCT04324736
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Primary Completion: 2020-04-10
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5309

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diabetes	no interventional study	-
Patients without diabetes	no interventional study	-

Primary Outcome Measures

Name	Time	Method
Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19	1 month	Prevalence of severe forms among all COVID-19 patients with diabetes

Secondary Outcome Measures

Name	Time	Method
describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19	1 month	Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.
describe the prognosis of hospitalized subjects with diabetes and COVID-19	1 month	death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
describe the care management of hospitalized subjects with diabetes and COVID-19	1 month	care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France