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"COVID-19 and Diabetes Outcomes" (CORONADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324736
Recruitment Status : Completed
First Posted : March 27, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date March 25, 2020
First Posted Date March 27, 2020
Last Update Posted Date February 23, 2021
Actual Study Start Date March 10, 2020
Actual Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2020)
Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19 [ Time Frame: 1 month ]
Prevalence of severe forms among all COVID-19 patients with diabetes
Original Primary Outcome Measures
 (submitted: March 25, 2020)
Assess the prevalence of severe forms among hospitalized COVID-19 diabetics [ Time Frame: 1 month ]
Prevalence of severe forms among all COVID-19 patients with diabetes
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2020)
  • describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures
 (submitted: March 25, 2020)
  • describe the clinical characteristics of diabetic subjects treated in hospital for COVID-19 [ Time Frame: 1 month ]
    Use of general socio-demographic characteristics of patients, type of diabetes, history of hypoglycaemia, complications associated with diabetes
  • describe the biological characteristics of diabetic subjects treated in hospital for COVID-19 [ Time Frame: 1 month ]
    Use of glycated hemoglobin, glucose at admission, fasting glucose in the first 3 days of follow-up, creatinine, liver function markers, blood count, nutritional markers, inflammatory markers, hemostasis
  • describe the prognosis of diabetic subjects hospitalized for COVID-19 [ Time Frame: 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 management of diabetic patients hospitalized for COVID-19 [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title "COVID-19 and Diabetes Outcomes"
Official Title "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population diabetic patients treated for COVID-19 in a hospital center and non diabetic patients treated for COVID-19 in a hospital center
Condition
  • Coronavirus
  • Diabetes
Intervention Other: no interventional study
no interventional study
Study Groups/Cohorts
  • Patients with diabetes
    Intervention: Other: no interventional study
  • Patients without diabetes
    Intervention: Other: no interventional study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 3, 2020)
5309
Original Estimated Enrollment
 (submitted: March 25, 2020)
300
Actual Study Completion Date December 31, 2020
Actual Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04324736
Other Study ID Numbers RC20_0148
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date February 2021