"COVID-19 and Diabetes Outcomes"

Diabetes Clinical Trial

— CORONADO  

Official title:

"Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324736
• Other study ID #: RC20_0148
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5309
• Est. completion date: December 31, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Diabetes
• Diabetes Mellitus

Intervention

Other:
• no interventional study
no interventional study

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19	Prevalence of severe forms among all COVID-19 patients with diabetes	1 month
Secondary	describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19	Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.	1 month
Secondary	describe the prognosis of hospitalized subjects with diabetes and COVID-19	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	1 month
Secondary	describe the care management of hospitalized subjects with diabetes and COVID-19	care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7	1 month